| Exclusivity code |
Explain the meaning of |
| D |
New Dosing Schedule (See Individual References) |
| D-1 |
Once A Day Application |
| D-10 |
Narcotic Overdose In Children |
| D-100 |
750 Mg Once Daily For Five Days For The Treatment Of Acute Bacterial Sinusitis |
| D-101 |
Once Daily In Chronic Idiopathic Uticaria For Adults And Children 12 Years Of Age And Older |
| D-102 |
New Dosing Regimen Of One Spray Twice Daily For Seasonal Alleric Rhinitis In Patients 12 Yrs Of Age And Older |
| D-103 |
New Dosing Recommendation For The Treatment Of Recurrent Genital Herpes In Immunocompetent Patients, Specifically A Reduction In Course Of Therapy From Famciclovir 125 Mg Twice-A-Day For 5 Days To 1000 Mg Twice-A-Day For 1 Day. |
| D-104 |
0.5mg/0.1mg For The Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause In Women Who Have A Uterus |
| D-105 |
Use Of Actonel 75mg Two Consecutive Days Per Month For The Prevention And Treatment Of Postmenopausal Osteoporosis |
| D-106 |
Five Day Treatment Of Selected Susceptible Strains Of Streptococcus Pneumoniae, Haemophilus Influenza, Mycoplasma Pneumoniae, And Chlamydia Pneumoniae For Community-Acquired Pneumonia |
| D-107 |
Provides For The Combination Tablet Of 70mg Alendronate And 5600 Iu Of Vitamin D3 For The Treatment Of Osteoporosis In Postmenopausal Women And To Increase Bone Mass In Men With Osteoporosis |
| D-108 |
Treatment Of Complicated Urinary Tract Infection And Acute Pyelonephritis With Levaquin 750mg Once Daily For Five Days |
| D-109 |
Provide For The Use Of A Lower Dose For The Treatment Of Adults With Chronic Phase Chronic Myeloid Leukemia (Cml) With Resistance Or Intolerance To Prior Therapy Including Imatinib Mesylate |
| D-11 |
Postoperative Narcotic Depression In Children |
| D-110 |
Treatment Of Schizophrenia In Adolescents Aged 13-17 |
| D-111 |
Provides For Once Daily Use Of Cialis, 2.5 Mg And 5 Mg, For The Treamtent Of Erectile Dysfunction |
| D-112 |
Provides For Pediatric Pump Use |
| D-113 |
Once Daily Dosing Regimen For Patients Who Become Constipated On Twice Daily Regimen |
| D-114 |
New Dosing Recommendations For Use Of Sirolimus In Combination With Cyclosporine For The Prophylaxis Of Rejection In High-Risk Renal Transplant Recipients |
| D-115 |
Starting Dose Of 15mg/Day For Monotherapy In Acute Treatment Of Bipolar Disorder, Manic Or Mixed |
| D-116 |
Alternative Dosing Regimen Atazanavir Sulate Co-Administered With Ritonavir For The Treatment Of Hiv-1 Infection In Treatment Naive Patients |
| D-117 |
50 Mg Tablet For Initiation Of Dose Titration For Bipolar Disorder |
| D-118 |
Two 400mg Tablets Once Daily, Co-Administered With 100mg Ritonavir |
| D-119 |
Dosing Recommendations For Hiv Infected Pediatric Patients 6 To Less Than 18 Years Of Age |
| D-12 |
Bedtime Dosing Of 800mg For Treatment Of Active Duodenal Ulcer |
| D-120 |
Dosing Regimen Adjustments |
| D-121 |
Change To Remove 20 Mg Maximum Dosage Restriction |
| D-122 |
Use Of Vagifem 10 Mcg For The Treatment Of Atrophic Vaginitis Due To Menopause |
| D-123 |
Alternative Dosing Regimen Dose Of 20 Mg/Meter Square By Continuous Intravenous Infusion Over 1 Hour Repeated Daily For 5 Days |
| D-124 |
Once Daily Dosing Regimen In Adult Patients With Less Than Three Lopinavir Resistance-Associated Substitutions |
| D-125 |
Extend Current Dosing Regimen To 900mg (2-450mg Tablets) Once A Day Within 10 Days Of Transplantation Until 200 Days Post-Transplantation For The Prevention Of Cytomegalovirus (Cmv) Disease In Adult Kidney Transplant Patients At High Risk. |
| D-126 |
Change Dosage Regimen From 250mg To 500mg |
| D-127 |
Dosing Regimen For Adult Patients With Chronic Hepatitis B (Chb) And Decompensated Liver Desease |
| D-128 |
Single Iv Dose Of Fosaprepitant 150mg, Dosed Concomitantly With 5ht3 Receptor Antagonist & Corticosteroid, For Prevention Of Acute & Delayed Nausea & Vomiting Associated With Initial And Repeat Courses Of Highly Emetogenic Cancer Chemo |
| D-129 |
800/100 Mg Darunavir/Ritonavir, Once Daily, In Treatment -Experienced Hiv-1 Infected Patients With No Darunivir Resistance Associated Subsitutions |
| D-13 |
Increased Maximum Daily Dosage Recommendation |
| D-130 |
Dosing Recommendations For Treatment Of Hiv-1 Infection During Pregnancy Based On Data From Study Ai424-182, A Study Of Atazanavir/Ritonavir In Combination With Zidovudine/Lamivudine In Hiv Infected Pregnant Women |
| D-131 |
Every 6 To 8 Weeks For The 120mg Strength For Patients Who Are Controlled On Somatuline Depot 60mg Or 90mg |
| D-132 |
45mg For 6 Month Administration |
| D-133 |
New Efficacy Data And Dosing Regimen For Pregnancy In Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation As Part Of An Ivf Or Intracytoplasmic Sperm Injection (Icsi) Cycle |
| D-134 |
Increasing Maximum Dosing Of Patients With Schizophrenia To 160 Mg/Day |
| D-14 |
Bedtime Dosing Of 800mg For Treatment Of Active Benign Gastric Ulcer |
| D-15 |
Single Daily Dose Of 25mg/37.5mg |
| D-16 |
Continuous Intravenous Infusion |
| D-17 |
400mg Every 12 Hours For Three Days For Uncomplicated Urinary Tract Infections |
| D-18 |
Lower Recommended Starting Dose Guidelines |
| D-19 |
Bolus Dosing Guidelines |
| D-2 |
Once Daily Dosing |
| D-20 |
Single 32mg Dose |
| D-21 |
Alternative Dosage Of 300mg Once Daily After The Evening Meal |
| D-22 |
Reduction In Infusion Time From 24 To 4 Hours For The 60mg Dose |
| D-23 |
Increase Maximum Dose And Variations In The Dosing Regimen |
| D-24 |
For Ovarian Cancer The Recommended Regimen Is 135mg/M2 Or 175mg/M2 Intravenously Over Three Hours Every Three Weeks |
| D-25 |
Additional Dosage Regimen Equal To Half The Original Dosing Regimen |
| D-26 |
Once Weekly Application |
| D-27 |
Bid Dosing In Patients 12 Years Of Age And Older For Prevention Of Nausea And Vomiting Associated With Moderate Emetogenic Cancer Chemotherapy |
| D-28 |
Use Of Isovue-370 In Excretory Urography At Equivalent Grams Of Iodine To The Currently Approved Isovue-250 And Isovue-300 |
| D-29 |
Increase Of Cumulative Dose To 0.3mmol/Kg For Mri Of Cns In Adults |
| D-3 |
Seven Days/Seven Days/Seven Days Dosing Schedule |
| D-30 |
5000 Iu Dose For Phophylaxix Against Deep Vein Thrombosis |
| D-31 |
Change In Recommended Total Daily Dose To 80mg (40mg Bid) |
| D-32 |
Removal Of The Restrictions Limiting Treatment To Two Consecutive Weeks And To Small Areas |
| D-33 |
Once Daily Dosing For Plaque Psoriasis |
| D-34 |
Every Four Months Dosage Regimen |
| D-35 |
For A One Week Dosing Of Interdigital Tinea Pedis |
| D-36 |
For A Single 2mg Dose As An Alternative To The 1mg Dose Given Twice Daily |
| D-37 |
Dosing Regimen For Administration Either Once Daily (Qd) Or Twice Daily (Bid) |
| D-38 |
Continuous Infusion As An Alternate Method Of Administration |
| D-39 |
Change In Time To Take The Drug Prior To A Meal To Prevent Meal-Induced Heartburn Symptoms From "..1/2 To 1 Hour Before Eating" To ".. Right Before Eating Or Up To 60min Before Consuming..." |
| D-4 |
Seven Days/Fourteen Days Dosing Schedule |
| D-40 |
Once-A-Day Dosing Regimen |
| D-41 |
Drug May Be Dosed Right Before A Meal Or Any Time Up To 30min Before Eating Or Drinking Food And Beverages That Would Be Expected To Cause Symptoms |
| D-42 |
Ten Day Dosing Regimen For Triple Therapy, Prevacid In Combination With Clarithromycin And Amoxicillin, For The Eradication Of H.Pylori In Patients With Duodenal Ulcer Disease |
| D-43 |
Initiation Of Treatment With 900mg/Day By Deletion Of The Requirement To Titrate To 900mg/Day Over A 3-Day Period |
| D-44 |
In A Clinical Trial, Fewer Discontinuations Due To Adverse Events, Especially Dizziness And Vertigo, Were Observed When Titrating The Dose In Increments Of 50mg/Day Every 3 Days Until An Effective Dose (Not Exceeding 400mg/Day) Was Reached |
| D-45 |
Once Daily Dosing For Maintenance Only |
| D-46 |
New Dosing Regimen Of 80mg Daily |
| D-47 |
Prevention Of Heartburn Symptoms When Administered From 15 Minutes Up To, But Not Including, 1 Hour Prior To A Provocative Meal |
| D-48 |
Adimistration Of Cisatricurium A Neuromuscular Blocking Agent At Doses Of 3 And 4x The Ed95 Of Cisatricurium Following Induction With Thiopental |
| D-49 |
Pediatric Dosing Guidelines |
| D-5 |
Ten Days/Eleven Days Dosing Schedule |
| D-50 |
Information For Use Of Corvert In Post-Cardiac Surgery Patients |
| D-51 |
Optional Starting Dose Of 40mg/Day |
| D-52 |
Alternate Dosing Regimen Of 1250mg Twice Daily |
| D-53 |
Use In Pediatric Patients From 1 Month To 16 Years Of Age |
| D-54 |
Use Of Zyban For Maintenance Therapy. Treatment Up To 6 Months Was Shown Efficacious |
| D-55 |
Addition Of A Higher Dose Of Nutropin For Pubertal Patients (Pubertal Dose Less Than Or Equal To 0.7mg/Kg/Week) |
| D-56 |
Addition Of Postprandial Dosing |
| D-57 |
3-Hour Infusion Of Taxol Given Every Three Weeks At A Dose Of 175mg/M2 Followed By Cisplatin At A Dose Of 75mg/M2 For The First-Line Treatment Of Advanced Ovarian Cancer |
| D-58 |
Change In Dosing Interval To Once-Daily Administration |
| D-59 |
Reduction Of Elevated Ldl-C In A New, Higher Strength Tablet, 0.8mg, And For Extension Of The Dosage Range To 0.8mg Daily |
| D-6 |
Seven Days/Nine Days/Five Days Dosing Schedule |
| D-60 |
Addition Of A Post-Operative Dosing Regimen |
| D-61 |
Once Weekly Dosing For The Treatment Of Postmenopausal Osteoporosis |
| D-62 |
Once Weekly Dosing For The Prevention Of Postmenopausal Osteoporosis |
| D-63 |
To Allow A Titration Dosing Regimen Using A 25mg Dose |
| D-64 |
Increasing Dosage For Nerve Block Anesthesia Using Naropin 7.5mg/Ml And For Extending The Duration Of Treatment For Postoperative Analgesia Using Naropin 2mg/Ml |
| D-65 |
Change Dosing And Administration To Indicate Maintenance Of Weight Loss Over An 18 Month Period Thus Extending The Use Of This Drug From One To Two Years |
| D-66 |
Dosing Recommendations For Patients Undergoing Pci |
| D-67 |
Shorter Treatment Course Of Three Days In The Treatment Of Recurrent Episodes Of Genital Herpes |
| D-68 |
Change Of Admin Rate For Infusion Of Aredia For Treatment Of Moderate And Severe Hypercalcemia Of Malignancy From 24 Hours To 2 Hours Up To But Not Including 24 Hours |
| D-69 |
Shortened Dosing Regimen To 5 Days For The Treatment Of Acute Exacerbation Of Chronic Bronchitis |
| D-7 |
Bid Dosing |
| D-70 |
80mg Once Daily Dosing Regimen |
| D-71 |
Eight Week Dosing Regimen |
| D-72 |
Information Regarding Increased Rate Of Infusion For Depacon |
| D-73 |
Once A Week Dosing For The Treatment Of Postmenopausal Osteoporosis |
| D-74 |
Once A Week Dosing For The Prevention Of Postmenopausal Osteoporosis |
| D-75 |
Intermittent Dosing Regimen, Starting Daily Dose 14 Days Prior To The Anticipated Onset Of Menstruation Through The First Full Day Of Menses And Repeating With Each New Cycle |
| D-76 |
For Use On An "As Needed" Or Prn Basis For The Management Of Nasal Symptoms In Patients For Whom The Drug Is Indicated |
| D-77 |
Addition Of 20mg And 40mg Daily As Optional Starting Doses With 40mg Intended For Patients Who Require A Large Reduction In Ldl-C (More Than 45%) |
| D-78 |
Use Of Flexeril 5mg For The Relief Of Muscle Spasm Associated With Acute, Painful, Musculoskeletal Conditions |
| D-79 |
New Lower Starting Dose For Treatment Of Moderate To Severe Vasomotor Symptoms And/Or Moderate To Severe Symptoms Of Vulvar And Vaginal Atrophy Associated W/ The Menopause |
| D-8 |
Intravenous, Epidural And Intrathecal Dosing |
| D-80 |
Change Of Dosing Schedule For Lantus From Once Daily At Bedtime To Flexible Daily Dosing |
| D-81 |
New Lower Starting Dose For The Prevention Of Postmenopausal Osteoporsis |
| D-82 |
Use Of Premarin 0.3 Mg And 0.45 Mg For The Prevention Of Postmenopausal Osteoporosis |
| D-83 |
750 Mg, Once Daily For 5 Days For Community Acquired Pneumonia (Cap) |
| D-84 |
Once-A-Day Dosing Of Floxacin Otic For The Treatment Of Adults And Pediatric Patients(Ages 6 Mo & Older) W/ Otitis Externa Caused By Susceptible Strains Of E.Coli, P.Aeruginosa And S.Aureus |
| D-85 |
Lower Recommended Starting Dose Guidelines For Treatment Of Moderate To Severe Vasomotor Symptoms Associated With The Menopause |
| D-86 |
For Use In Select External Insulin Pumps |
| D-87 |
Addition Of Once-Weekly Dosing For The Treatment To Increase Bone Mass In Men With Osteoporosis |
| D-88 |
New Dosing Range Of 200-400mg Per Day In Two Divided Doses For Adults With Partial Seizures |
| D-89 |
Use Of Reyataz 300 Mg/Ritonavir 100 Mg Once Daily For Treatment In Hiv-Infected Antiretroviral-Experienced Patients |
| D-9 |
Narcotic Overdose In Adults |
| D-90 |
Addition Of Daytime Administration To Treat Vulvovaginal Candidiasis |
| D-91 |
Alternate Intermittent Dosing Regimen |
| D-92 |
Alternative Dosage Of 1000mg Once Daily At Bedtime |
| D-93 |
Alternate Two Or Three Times Daily Dosing Regimens |
| D-94 |
New Maximum Dosage Of 72 Mg/Day In Adolescents 13-17 Years Of Age With Attention Defecit Hyperactivity Disorder (Adhd) |
| D-95 |
Broadened Initial Starting Dose For Hypertension From 50 Mg To 100 Mg To 25 Mg To 100 Mg Dose Range |
| D-96 |
Once-Monthly Treatment Of Postmenopausal Osteoporosis With Boniva (Ibandronate Sodium) 150 Mg Tablets |
| D-97 |
Ped Cancer Pt Population Expanded To Include Pts 6 Mos Up To But Not Including 4 Yrs And Dosing Instructions To Admin 30 Min Befpre Chemo With Second And Third Doses 4 & 8 Hours After First Dose |
| D-98 |
Dosing For Ped Surgical Pts Expanded To Include Pts 1 Month Up To But Not Including 2 Years Of Age |
| D-99 |
Once Daily Administration For The Treatment Of Hiv Infection In Therapy Naive Adult Patients |
| I |
New Indication (See Individual References) |
| I-1 |
Dysmenorrhea |
| I-10 |
Prevention Of Postoperative Deep Venous Thrombosis And Pulmonary Embolism In Total Hip Replacement Surgery |
| I-100 |
To Decrease The Incidence Of Candidiasis In Patients Undergoing Bone Marrow Transplantation Who Receive Cytotoxic Chemotherapy And/Or Radiation Therapy |
| I-101 |
Treatment Of Diabetic Nephropathy In Patients With Type I Insulin-Dependent Diabetes Mellitus And Retinopathy |
| I-102 |
Treatment Of Obsessive-Compulsive Disorder |
| I-103 |
Prophylaxis Against Pneumocystis Carinii Pneumonia In Individuals Who Are Immunocompromised And Considered To Be At Risk Of Developing Pneumocystis Carinii Pneumonia |
| I-104 |
Treatment Of Pulmonary And Extrapulmonary Aspergillosis In Patents Who Are Intolerant Of Or Who Are Refractory To Amphotericin B Therapy |
| I-105 |
Treatment Of Metastatic Carcinoma Of The Breast After Failure Of First-Line Or Subsequent Chemotherapy |
| I-106 |
Treatment Of Acromegaly |
| I-107 |
Vaginal Candidiasis |
| I-108 |
Expanded Use-For Icu Patients Undergoing Long-Term Infusion During Mechanical Ventilation |
| I-109 |
Typhoid Fever |
| I-11 |
Relief Of Mild To Moderate Pain |
| I-110 |
Prevention Of Nausea And Vomiting Associated With Radiotherapy |
| I-111 |
Treatment Of Paget's Disease Of Bone |
| I-112 |
Management Of Moderate To Severe Pain |
| I-113 |
Treatment Of Prostatitis |
| I-114 |
Use In Children To Visualize Lesions With Abnormal Vascularity In The Brain (Intracranial Lesions), Spine, And Associated Tissue |
| I-115 |
Use In Mri In Adults To Visualize Lesions In The Head And Neck |
| I-116 |
Maintenance Of Healing Of Erosive Esophagitis |
| I-117 |
To Slow The Progression Fo Coronany Atherosclerosis In Patients With Coronary Heart Disease |
| I-118 |
Prevention Of Deep Vein Thrombosis, Which May Lead To Pulmonary Embolism Following Knee Replacement Surgery |
| I-119 |
Treatment Of Anemia Caused By Uterine Leiomyomata In Women Who Fail Iron Therapy |
| I-12 |
Treatment Of Cutaneous Candidiasis |
| I-120 |
Maintenance Therapy For Gastric Ulcer Patients At Reduced Dosage After Healing Acute Ulcers |
| I-121 |
Expanded Patient Population -- Use In Icu Patients |
| I-122 |
Psoriasis Of The Scalp |
| I-123 |
Relief Of Mild To Moderate Pain In Patients Aged 6 Months And Older |
| I-124 |
Leucocyte Labeled Scintigraphy As An Adjunct In The Localization Of Intra-Abdominal Infection And Inflammatory Bowel Disease |
| I-125 |
Expansion Of Conscious Sedation Indication To Include Short Therapeutic Procedures |
| I-126 |
Adjunct To Thallium- 201 Myocardial Perfusion In Patients Unable To Exercise Adequately |
| I-127 |
Treatment Of Acyclovir-Resistant Herpes In Immunocompromised Patients |
| I-128 |
In Pt W/ Ch Disease And Hypercholesterolemia: Reduce Risk Total Mortality By Reducing Coronary Death; Reduce Risk Non-Fatal Mi; Reduce Risk Undergoing Myocardial Revascularization Procedures; Reduction Elevated Total And Ldl Chol Levels... |
| I-129 |
Treatment Of Alcohol Dependence |
| I-13 |
Urinary Tract Infection (Uti) Prevention For Periods Up To Five Months In Women With A History Of Recurrent Uti |
| I-130 |
Maintenance Of Healing Of Erosive Esophagitis |
| I-131 |
Peripheral Arteriography |
| I-132 |
Treatment Of Manic Phase Of Bipolar Disorder |
| I-133 |
Management Of Chronic Stable Angina |
| I-134 |
Heart Failure Post Myocardial Infarction |
| I-135 |
Bone Metastases Associated With Multiple Myeloma |
| I-136 |
Idiopathic Chronic Urticaria |
| I-137 |
Prevention Of Metal-Induced Heart Burn, Acid Indigestion, And Sour Stomach When Taken 30 Minutes Prior To Consuming Food Or Beverages |
| I-138 |
Treatment Of Acute Recurrent Genital Herpes |
| I-139 |
Palliative Treatment Of Advanced Breast Cancer In Pre- And Perimenopausal Women |
| I-14 |
Seborrheic Dermatitis |
| I-140 |
Prevention Of Cytomegalovirus (Cmv) Disease In Individuals With Hiv Infection At Risk For Developing Cmv Disease |
| I-141 |
Treatment Of Hemodynamically Stable Patients Within 24 Hours Of Acute Myocardial Infarction To Improve Survival |
| I-142 |
Localize Myocardial Ischemia(Reversible Defect) And Infarction (Non-Reversible Defects) In Evaluating Myocardial Function |
| I-143 |
Episodic Treatment Of Recurrent Genital Herpes In Immunocompetent Adults |
| I-144 |
Enhancement Of Mri Of The Adult Body Internal Organs |
| I-145 |
0.1mmol/Kg As A Single Intraveous Bolus For Mri Of The Cns In Children |
| I-146 |
Contrast Enhancement And Facilitation Of Visualization Of Extracranial Head And Neck Lesions |
| I-147 |
Prevention Of Gallstone Formation In Obese Patients Experiencing Rapid Weight Loss |
| I-148 |
Treatment Of Acute Pneumocystic Carini Pneumonia (Pcp) In Hiv-Infected Patients Whose Alveolar-Arterial Oxygen Difference (Aado2) Is Less Than Or Equal To 55 Torr |
| I-149 |
Treatment Of Patients With Non-Small Cell Lung Cancer |
| I-15 |
Photopheresis In The Palliative Treatment Of Skin Manifestations Of Cutaneous T-Cell Lymphoma In Persons Not Responsive To Other Treatment |
| I-150 |
Treatment Of Obsessive Compulsive Disorder And Panic Disorder |
| I-151 |
Prevention Of And Prevention Of Further Postoperative Nausea And Vomiting In Pediatric Patients Receiving General Anesthesia |
| I-152 |
Slowing The Progression Of Coronary Atherosclerosis And Reducing The Risk Of Acute Coronary Events |
| I-153 |
Management Of Severe Spasticity [Encompases Spinal And Cerebral Origin] |
| I-154 |
Patient Population Altered To Include Pediatric Use |
| I-155 |
Treatment Of Onchomycosis Due To Dermatophytes (Tinea Unguium) Of The Toenail With Or Without Fingernail Involvement |
| I-156 |
Additional Data Regarding The Safe Use Of Norvasc In Patients With Heart Failure |
| I-157 |
Treatment Of Acute Uncomplicated Cystitis In Females |
| I-158 |
Treatment Of Osteolytic Bone Metastases Of Breast Cancer |
| I-159 |
For Hypercholesterolemic Patients Without Clinically Evident Heart Disease Reduce The Risk Of Myocardial Infarction, Revascularization, And Death Due To Cardiovascular Causes With No Increase In Death From Non-Cardiovascular Causes |
| I-16 |
Stimulate The Development Of Multiple Follicles/Oocytes In Ovulatory Patients Participating In An In Vitro Fertilization Program |
| I-160 |
Treatment Of Bacterial Corneal Ulcers |
| I-161 |
Treatment Of Adult-Onset Or Childhood-Onset Adult Growth Hormone Deficiency |
| I-162 |
For Use In Patients 6-11 Years Of Age |
| I-163 |
Treatment Of Photophobia |
| I-164 |
Chronic Bacterial Prostatitis |
| I-165 |
Management Of Adults With Active, Classic And Definitive Rheumatoid Arthritis Who Have Had Insufficient Therapeutic Response To Or Are Intolerant Of An Adequate Trial Of Full Doses Of One Or More Non-Steroidal Anti-Inflammatory Drugs |
| I-166 |
Treatment Of Bulimia |
| I-167 |
Complicated Intra-Abdominal Infections (Used In Combination With Metronidazole) Caused By Mixed Aerobic/Anaerobic Pathogens |
| I-168 |
Management Of Locally Confined Stage B2-C Metastatic Carcinoma Of The Prostate (In Combination With Lhrh Agonists) |
| I-169 |
Use In Combination With Corticosteroids As Initial Chemotherapy For The Treatment Of Patients With Pain Related To Advanced Hormone-Refractory Prostate Cancer |
| I-17 |
Management Of Congestive Heart Failure |
| I-170 |
Prophylactic Use During Head Lice Epidemics |
| I-171 |
Relief Of Symptoms Of The Common Cold |
| I-172 |
Treatment Of Initial Episode Of Genital Herpes |
| I-173 |
Preoperatively For The Prevention Of Infection In Transrectal Prostate Biopsy |
| I-174 |
Pelvic Inflammatory Disease |
| I-175 |
Treatment Of Tinea Corporis And Tinea Cruris |
| I-176 |
Treatment Of Postoperative Inflammation In Patients Who Have Undergone Cataract Extraction |
| I-177 |
Tx Of Moderate Acne Vulgaris In Females,Greater Or Equal To 15yrs Of Age,Who Have No Known Contraindications To Oral Contraceptive Therapy,Desire Contraception,Have Achieved Menarche And Are Unresponsive To Topical Anti-Acne Medications |
| I-178 |
Treatment Of Onchomycosis Of The Fingernail Without Concomitant Onchomycosis Of The Toenail With A Pulse Dosing Regimen |
| I-179 |
Nosocomial Pneumonia-Mild To Moderate And Severe Caused By Haemophilus Influenzae Or Klebsiella Pneumoniae |
| I-18 |
Endoscopic Retrograde Pancreatography |
| I-180 |
Treatment Of Plantar Tinea Pedis (Moccasin Type) |
| I-181 |
Treatment Of Patients With Complex Partial Seizures With And Without Secondary Generalization |
| I-182 |
Treatment Of Growth Failure Associated With Turner Syndrome |
| I-183 |
Maintenance Therapy In The Management Of Mild To Moderate Asthma In Pediatric Patients Ages 6-11 |
| I-184 |
Treatment Of Panic Disorder At A Recommended Dose Range Of 1 To 2mg/Day (Maximum Of 4mg) |
| I-185 |
Prevention Of Osteoporosis In Postmenopausal Women |
| I-186 |
Treatment Of Tinea (Pityriasis) Versicolor Caused By Or Presumed To Be Caused By Pityrosporum Orbiculare (Also Known As Malassezia Furfur Or M. Orbiculare) |
| I-187 |
Prevention Of Fractures In The Treatment Of Postmenopausal Osteoporosis |
| I-188 |
Treatment Of Acute Sinusitis And Acute Exacerbation Of Chronic Sinusitis |
| I-189 |
Treatment Of Acute Otitis Media In Pediatric Patients |
| I-19 |
Herniography |
| I-190 |
Planar Imaging As A Second Line Diagnostic Drug After Mammography To Assist In The Evaluation Of Breast Lesions In Patients With An Abnormal Mammogram Or A Palpable Breast Mass |
| I-191 |
Endometrial Thinning Agent Prior To Endometrial Ablation For Dysfunctional Uterine Bleeding |
| I-192 |
The Prevention Of Deep Vein Thrombosis, Which May Lead To Pulmonary Embolism, In Patients Undergoing Abdominal Surgery Who Are At Risk For Thromboembolic Complications And A New Dosage Regimen, 40mg Once Daily, For This Indication |
| I-193 |
Treatment Of Panic Disorder In A Recommended Dose Range Of 50 To 200mg/Day |
| I-194 |
Congestive Heart Failure |
| I-195 |
For Use Of Lansoprazole In Combination With Clarithromycin And Amoxicillin For The Eradication Of Helicobacter Pylori In Patients With Active Duodenal Ulcer Disease Or A One-Year History Of Duodenal Ulcer |
| I-196 |
Acute Treatment Of Active Benign Gastric Ulcer |
| I-197 |
Maintenance Of Healing Of Duodenal Ulcer |
| I-198 |
For The Use Of Lansoprazole In Combination With Amoxicillin For The Eradication Of Helicobacter Pylori In Patients With Active Duodenal Ulcer Disease Or A One-Year History Of A Duodenal Ulcer |
| I-199 |
Monotherapy And Combination Therapy With Sulfonyl Ureas In The Treatment Of Type Ii Diabetes |
| I-2 |
Cholangiopancreatography |
| I-20 |
Knee Arthrography |
| I-200 |
Treatment Of Tinea (Pityriasis) Versicolor |
| I-201 |
Empirical Therapy For Febrile Neutropenic Patients |
| I-202 |
Second-Line Treament Of Aids-Related Kaposi's Sarcoma |
| I-203 |
Maintenance Of Remission Of Ulcerative Colitis |
| I-204 |
Use In Pediatric Patients Between The Ages Of 6 And 11 For The Treatment Of The Nasal Symptoms Of Seasonal And Perennial Allergic Rhinitis |
| I-205 |
Initial Anticonvulsant Treatment Of Status Epilepticus |
| I-206 |
Treatment Of Edema Associated With Chronic Renal Failure |
| I-207 |
For The Suppression Of Recurrent Episodes Of Genital Herpes In Immunocompetent Adults |
| I-208 |
Treatment Of Obsessive Compulsive Disorder In The Pediatric Population |
| I-209 |
Paroxysmal Supraventricular Tachycardia (Psvt) |
| I-21 |
High Dose Methotrexate With Leucovorin Rescue In Combination With Other Chemotherapeutic Agents To Delay Recurrence In Patients With Nonmetastatic Osteosarcoma Who Have Undergone Surgical Resection Or Amputation For The Primary Tumor |
| I-210 |
To Slow The Progression Of Coronary Atherosclerosis In Patients With Coronary Heart Disease As Part Of A Treatment Strategy To Lower Total And Ldl Cholesterol To Target Levels |
| I-211 |
For Use In Pediatric Population |
| I-212 |
Treatment Of Symptoms Of Dry Mouth In Patients With Sjogren's Syndrome |
| I-213 |
Temporary Relief Of Pain And Photophobia In Patients Undergoing Corneal Refractive Surgery |
| I-214 |
Treatment Of Osteoporosis |
| I-215 |
Pre-Procedural Application To Adult Male Genital Skin Prior To Site-Specific Subcutaneous Infiltration With Lidocaine For The Removal Of Genital Warts |
| I-216 |
For The Long-Term Twice-Daily (Morning And Evening) Administration In The Maintenance Treatment Of Bronchospasm Associated With Copd, Including Chronic Bronchitis And Emphysema |
| I-217 |
Prevention (During And Following Hospitalization) Of Deep Vein Thrombosis, Which May Lead To Pulmonary Embolism, In Patients Undergoing Hip Replacement Surgery |
| I-218 |
Use Of Lipitor As An Adjunctive Therapy To Diet For The Treatment Of Patients With Elevated Serum Triglyceride Levels (Frederickson Type Iv) |
| I-219 |
Use Of Lipitor By Patients With Primary Dysbetalipoproteinemia (Frederickson Type Iii) Who Do Not Respond Adequately To Diet |
| I-22 |
Rescue After High-Dose Methotrexate Therapy In Osteosarcoma |
| I-220 |
Treatment Of Episodic- Heartburn, Acid Indigestion And Sour Stomach |
| I-221 |
Treatment Of Benign Prostatic Hyperplasia (Bph) In Men With An Enlarged Prostate To Improve Symptoms, Reduce The Risk Of Acute Urinary Retention And Reduce The Risk Of The Need Of Surgery |
| I-222 |
Prevention Of Ischemic Complications Of Unstable Angina And Non-Q-Wave Myocardial Infarction, When Concurrently Administered With Aspirin |
| I-223 |
Use In The Symptomatic Relief Of Rhinorrhea Associated With Allergic And Nonallergic-Perennial Rhinitis In Children Age 6-11 Years |
| I-224 |
For The Use In Pediatric Patients 4 To 11 Years Of Age For The Management Of The Nasal Symptoms Of Seasonal And Perennial Allergic Rhinitis |
| I-225 |
Use In Patients With Previous Mi And Normal Cholesterol Levels, To Reduce Risk Of Recurrent Mi, Myocardial Revascularization, And Cerebrovascular Disease Events |
| I-226 |
First-Line Therapy For The Treatment Of Advanced Carcinoma Of The Ovary In Combination With Cisplatin |
| I-227 |
Short-Term Treatment Of Symptomatic Gastroesphageal Reflux Disease (Gerd) |
| I-228 |
Prevention Of Meal Induced Heartburn At A Dose Of 75mg Taken 30-60min Prior To A Meal |
| I-229 |
Prilosec (Omeprazole), Amoxicillin, And Clarithromycin For The Eradication Of H. Pylori In Patients With Duodenal Ulcer Disease |
| I-23 |
Short-Term Treatment Of Active Benign Gastric Ulcer |
| I-230 |
In Combination With Cis-Platin, For The First Line Treatment Of Non-Small Cell Lung Cancer In Patients Who Are Not Candidates For Potentially Curative Surgery And/Or Radiation |
| I-231 |
Treatment Of Patients With Locally Advanced Or Metastatic Breast Cancer After Failure Of Prior Chemotherapy |
| I-232 |
Treatment Of Recurrent Mucocutaneous Herpes Simplex Infections In Hiv-Affected Patients At A Dose Of 500mg Twice Daily |
| I-233 |
Prophylactic Use To Reduce Perioperative Blood Loss And The Need For Blood Transufsion In Patients Undergoing Cardiopulmonary Bypass In The Course Of Coronary Artery Bypass Graft Surgery |
| I-234 |
For Use In Combination With Cisplatin For The First-Line Treatment Of Patients With Inoperable Locally Advanced (Stage Iiia Or Iiib) Or Metastatic (Stage Iv) Non-Small Cell Lung Cancer |
| I-235 |
Prevention Of Exercise-Induced Bronchospasm In Patients 12 Years Of Age And Older |
| I-236 |
Prevention Of Exercise-Induced Bronchospasm In Patients 4 Years Of Age And Older |
| I-237 |
Maintenance Treatment Of Asthma And Prevention Of Bronchospasm In Patients 4 Years Of Age And Older |
| I-238 |
Adjunctive Treatment Of Lennox-Gastaut Syndrome In Pediatric And Adult Patients |
| I-239 |
Treatment Of Patients With Homozygous Familial Hypercholesterolemia |
| I-24 |
Treatment Of Rheumatoid Arthritis |
| I-240 |
Management Of Secondary Hyperparathyroidism And Resultant Metabolic Bone Disease In Patients With Moderate To Severe Chronic Renal Failure (Ccr 15 To 55ml/Min) Not Yet On Dialysis |
| I-241 |
Use In Photodynamic Therapy (Pdt) For Reduction Of Obstruction And Palliation Of Symptoms In Patients With Completely Or Partially Obstructing Endobronchial Nonsmall Cell Lung Cancer |
| I-242 |
Treatment Of Moderate To Severe Vasomotor Symptoms Associated With The Menopause And In The Treatment Of Vulvar And Vaginal Atrophy In Women With An Intact Uterus |
| I-243 |
Use In The Symptomatic Relief Of Rhinorrhea Associated With The Common Cold In Children Age 5 To 11 Years |
| I-244 |
Reduce The Incidence Of Breast Cancer In Women At High Risk For Breast Cancer |
| I-245 |
Treatment Of Acute Sinusitis |
| I-246 |
Treatment Of Uncomplicated Urinary Tract Infections |
| I-247 |
Use In Conversion To Monotherapy In Adults With Partial Seizures Who Are Receiving Treatment With A Single Enzyme-Inducing Antiepileptic Drug |
| I-248 |
Inpatient Treatment Of Acute Deep Vein Thrombosis With/Without Pulmonary Embolism When Admin With Warfarin Sodim And Outpatient Treatment Of Acute Deep Vein Thrombosis Without Pulmonary Embolism When Admin With Warfarin Sodium |
| I-249 |
Treatment Of Chronic Hepatitis C In Patients With Compensated Liver Disease Previously Untreated With Alpha Interferon Therapy |
| I-25 |
Adult Intra-Arterial Digital Subtraction Angiography Of The Head, Neck, Abdominal, Renal And Peripheral Vessels |
| I-250 |
Primary Prevention Of Coronary Heart Disease In Patients Without Sympatomatic Cardiovascular Disease Who Have Average To Moderately Elevated Total-C And Ldl-C And Below Average Hdl-C |
| I-251 |
Treatment Of Generalized Anxiety Disorder |
| I-252 |
New Combination Use Of Precose For Patients With Type 2 Diabetes Treated With Diet Plus Metformin |
| I-253 |
Combination Use Of Precose For Patients With Type 2 Diabetes Treated With Diet Plus Insulin |
| I-254 |
Prevention Of Postmenopausal Osteoporosis (Loss Of Bone Mass) |
| I-255 |
Prevention Of Pneumocystis Carinii Pneumonia (Pcp) |
| I-256 |
Use In Treatment Of Small Cell Lung Cancer Sensitive Disease After Failure Of First-Line Chemotherapy |
| I-257 |
Treatment Of Chronic Hepatitis B Associated With Evidence Of Hepatitis B Viral Replication And Active Liver Inflamation |
| I-258 |
For Perennial Nonallergic Rhinitis For Ages 4 And Above |
| I-259 |
Prophylaxis Of Deep Vein Thrombosis (Dvt), Which May Lead To Pulmonary Embolism, In Patients Undergoing Hip Replacement Surgery |
| I-26 |
Treatment Of Liver Flukes |
| I-260 |
Expanded Pediatric Use In Children Younger Than One Month Of Age To Birth (With A Gestational Age Of 37 Weeks Or Greater) |
| I-261 |
Treatment Of Social Anxiety Disorder |
| I-262 |
Treatment Or Prevention Of Bronchospasm With Reversible Obstructive Airway Disease And For The Prevention Of Exercise Induced Bronchospasm In Children Ages 4-12 |
| I-263 |
Treatment Of Unstable Angina And Non-Q-Wave Myocardial Infarction For The Prevention Of Ischemic Complications In Patients On Concurrent Aspirin Therapy |
| I-264 |
Prevention Of Nausea And Vomiting Associated With Radiation, Including Total Body Irradiation (Tbi) And Fractionated Abdominal Radiation |
| I-265 |
Treatment Of Atopic Dermatitis In Pediatric Patients 6 Years And Older |
| I-266 |
Use Of Topamax As Adjunctive Therapy In Pediatric Patients Ages 2-16 Years With Partial Onset Seizures |
| I-267 |
Use In Pediatric Patients 3 Months Old And Older - For Corticosteroid-Responsive Dermatoses |
| I-268 |
Prophylaxis And Chronic Treatment Of Asthma In Patients 7-11 Years Of Age |
| I-269 |
Prevention Of Nausea And Vomiting Associated With Highly Emetogenic Cancer Chemotherapy, Including Cisplatin |
| I-27 |
Adjunctive Therapy To Diet To Reduce The Risk Of Coronary Artery Disease |
| I-270 |
Adjuvant Treatment Of Node-Positive Breast Cancer Administrered Sequentially To Standard Doxorubicin-Containing Combination Chemotherapy |
| I-271 |
Treatment Of Osteoporosis In Postmenopausal Women |
| I-272 |
Treatment Of Glucocorticoid-Induced Osteoporosis In Men And Women Receiving Glucocorticoids In A Daily Dose Equivalent To 7.5mg Or Greater Of Prednisone And Who Have Low Bone Mineral Density |
| I-273 |
Adjunct To Diet To Increase Hdl-C In Patients With Primary Hypercholesterolemia (Heterozygous Familial And Non Familial) And Mixed Dyslipidemia (Frederickson Types Iia And Iib) |
| I-274 |
Use Of Topamax As Adjunctive Therapy In The Treatment Of Primary Generalized Tonic-Clonic Seizures |
| I-275 |
Use In Combination With Metformin And Sulfonylurea In Patients With Type 2 Diabetes |
| I-276 |
Use Of Rezulin In Combination With Metformin And Sulfonylureas In Patients With Type 2 Diabetes |
| I-277 |
Treatment Of Type Iii Hyperlipoproteinemia |
| I-278 |
Treatment Of Patients With Isolated Hypertriglyceridemia (Frederickson Type Iv) |
| I-279 |
Treatment Of Post-Traumatic Stress Disorder |
| I-28 |
Selective Adult Visceral Arteriography |
| I-280 |
Use Of Carnitor Injection For The Prevention And Treatment Of Carnitine Deficiency In Patients With End Stage Renal Disease Who Are Undergoing Dialysis |
| I-281 |
Increasing Hdl-C In Patients With Primary Hypercholesterolemia (Heterozygous Familial And Nonfamilial) And Mixed Dyslipidemia (Frederickson Types Iia And Iib) |
| I-282 |
Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer After Failure Of Prior Platinum-Based Chemotherapy |
| I-283 |
To Reduce The Incidence Of Moderate To Severe Xerostomia In Patients Undergoing Post-Operative Radiation Treatment For Head And Neck Cancer, Where The Radiation Port Includes A Substantial Portion Of The Parotid Glands |
| I-284 |
To Reduce The Number Of Adenomatous Colorectal Polyps In Familial Adenomatous Polyposis Patients As An Adjunct To Usual Care |
| I-285 |
Treatment Of Nasal Symptoms Of Seasonal And Perennial Rhinitis In Adults And Children 3 Years Of Age And Older |
| I-286 |
Treatment Of Patients With Frederickson Type Iii |
| I-287 |
Use Of Pravastatin In Patients With Evident Coronary Heart Disease To Reduce The Risk Of Total Mortality By Reducing Coronary Death |
| I-288 |
Changes In Several Sections Of The Insert To Incorporate Statements Concerning The Use Of High Doses Of Lisinopril To Reduce The Risk Of The Combined Outcomes Of Mortality And Hospitalization In Patients With Congestive Heart Failure |
| I-289 |
Use Of Avandia In Combination With A Sulfonylurea In Patients With Type 2 Diabetes Melllitus When Diet And Exercise With Either Single Agent Does Not Achieve Adequate Glycemic Control |
| I-29 |
Metastatic Breast Cancer In Premenopausal Women As An Alternative To Oophorectomy Or Ovarian Irradiation |
| I-290 |
Prevention Of Corticosteroid-Induced Osteoporosis |
| I-291 |
Prevention Of Postmenopausal Osteoporosis |
| I-292 |
Treatment Of Postmenopausal Osteoporosis |
| I-293 |
Treatment Of Corticosteroid-Induced Osteoporosis |
| I-294 |
Treatment Of Uncomplicated Acute Illness Due To Influenza A And B In Pediatric Patients 7 Years And Older Who Have Been Symptomatic For No More Than 2 Days |
| I-295 |
Prevention Of Postmenopausal Osteoporosis For Women With An Intact Uterus |
| I-296 |
Long-Term Intravenous Treatment Of Pulmonary Hypertension Associated With The Scleroderma Spectrum Of Disease In Nyha Class Iii And Class Iv Patients Who Do Not Respond To Conventional Therapy |
| I-297 |
Short-Term Treatment Of Acute Manic Episodes Associated With Bipolar I Disorder |
| I-298 |
Treatment Of Patients With Frederickson Type Iia And Iib Hyperlipoproteinemia |
| I-299 |
Use Of Camptosar As A Component Of First-Line Therapy In Combination With 5-Flurouracil And Leucovarin For Patients With Metastatic Carcinoma Of The Colon Or Rectum |
| I-3 |
Intravenous Digital Subtraction Angiography |
| I-30 |
Treatment Of Tinea Pedis |
| I-300 |
Prophylaxis For Asthma In Children 2-5 Years Of Age |
| I-301 |
Treatment Of Signs And Symptoms Of Allergic Conjunctivitis |
| I-302 |
Treatment Of Pediatric Patients With Prader-Willi Syndrome |
| I-303 |
Increasing Hdl-Cholesterol In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemias |
| I-304 |
Treatment Of Patients With Frederickson Type Iv |
| I-305 |
Treatment Of Levofloxacin Susceptible Strains Of Penicillin-Resistant Streptococcus Pneumoniae In Patients With Community Acquired Pneumonia |
| I-306 |
Induction Of Spermatogenesis In Men With Primary And Secondary Hypogonadotropic Hypogonadism In Whom The Cause Of Infertility Is Not Due To Primary Testicular Failure |
| I-307 |
New Combination Use Of Metformin And Insulin In Type 2 Diabetes |
| I-308 |
Treatment Of Pediatric Patients With Polyarticular Course Juvenile Rheumotoid Arthritis Who Responded Inadequately To Salicylates Or Other Nsaids |
| I-309 |
Use Of Actonel 35mg Once A Week To Increase Bone Mass In Men With Osteoporosis |
| I-31 |
Contrast Enhancement Agent To Facilitate Visualization Of Lesions In The Spine And Associated Tissues |
| I-310 |
Reduction In Risk Of Myocardial Infarction, Stroke, And Death From Cardiovascular Causes |
| I-311 |
Adjunctive Therapy In The Treatment Of Partial Seizures In Pediatric Patients Age 3 To 12 Years |
| I-312 |
First Line Treatment Of Postmenopausal Women With Hormone Receptor Positive Or Hormone Receptor Unknown Locally Advanced Or Metastatic Breast Cancer |
| I-313 |
Extension Of Indication To Provide For Maintenance Of Response |
| I-314 |
Topical Anesthetic For Superficial Minor Surgery Of Genital Mucous Membranes And As An Adjunct For Local Infiltration Anesthesia In Genital Mucous Membranes |
| I-315 |
Thromboprophylaxis Of Deep Vein Thrombosis, Which May Lead To Pulmonary Embolism,In Medical Patients Who Are At Risk For Thromboembolic Complications Due To Severely Restricted Mobility During Acute Illness |
| I-316 |
Treatment Of Nsaid-Associated Gastric Ulcer Patients Who Continue Nsaid Use And Reducing Risk Of Nsaid-Associated Gastric Ulcers In Patients With History Of Documented Gastric Ulcer Who Require Use Of An Nsaid |
| I-317 |
Prophylaxis Of Influenza In Adults And Adolescents 13 Years And Older |
| I-318 |
Firstline Treatment Of Postmenopausal Women With Hormone Receptor Positive Or Hormone Receptor Unknown Locally Advanced Or Metastatic Breast Cancer |
| I-319 |
Use For Suspected Or Confirmed Methanol Poisoning, Either Alone Or In Combination With Hemodialysis |
| I-32 |
Pediatric Myelography |
| I-320 |
Treatment Of Type 2 Diabetes In Pediatric Patients (Ages 10-16 Years) |
| I-321 |
Juvenile Rheumatoid Arthritis |
| I-322 |
Use Of Diprivan In Patients 3 Months To 16 Years |
| I-323 |
Colorectal Cancer |
| I-324 |
Reducing Neurologic Disability And/Or Frequency Of Clinical Relapses In Patients With Secondary (Chronic) Progressive, Progressive Relapsing, Or Worsening Relapsing-Remitting Multiple Sclerosis |
| I-325 |
Prevention Of Relapse And Recurrence Of Depression |
| I-326 |
Generalized Anxiety Disorder |
| I-327 |
Symptomatic Relief Of Rhinorrhea Associated With Seasonal Allergic Rhinitis In Patients 5 Years And Older |
| I-328 |
Prophylaxis And Chronic Treatment Of Asthma In Patients 5-6 Years Of Age |
| I-329 |
Uncomplicated Skin And Skin Structure Infections |
| I-33 |
Oral Use Of Diluted Omnipaque Injection In Adults For Contrast Enhanced Computed Tomography Of The Abdomen |
| I-330 |
Maintenance Of Healing Of Erosive Esophagitis And Control Of Daytime And Nighttime Heartburn Systoms In Patients With Gerd |
| I-331 |
Treatment Of Moderate Acne Vulgaris |
| I-332 |
Empiric Therapy In Febrile Neutropenic Patients With Suspected Fungal Infections (Eftn) |
| I-333 |
Topical Treatment Of Tinea (Pityriasis) Versicolor Due To Malassezia Furfur (Formerly Pityrosporum Orbiculare) |
| I-334 |
Long-Term Treatment Of Growth Failure In Children Born Small For Gestational Age Who Fail To Manifest Catch-Up Growth By Two Years Of Age |
| I-335 |
Adjunctive Therapy In Patients Two Years And Older With Seizures Associated With Lennox-Gastaut Syndrome |
| I-336 |
Expansion Of Indication To Include The Treatment Of Patients With Predominately Classic Subfoveal Choroidal Neovascularization Due To Pathologic Myopia Or Presumed Ocular Histoplasmosis |
| I-337 |
Pathological Hypersecretion Associated With Zollinger-Ellison Snydrome |
| I-338 |
Management Of Acute Pain In Adults And Treatment Of Primary Dysmenorrhea |
| I-339 |
Treatment Of Hepatitis B In Pediatric Patients Ages 2-17 Years |
| I-34 |
Oral Use In Adults For Pass-Through Examination Of The Gastrointestinal Tract |
| I-340 |
Atopic Dermatitis In Pediatric Patients Ages 2-5 |
| I-341 |
Breast Cancer Combination Therapy |
| I-342 |
Use Of Foradil For Long-Term, Twice Daily (Morning And Evening) Administration In The Maintenance Treatment Of Broncho-Constriction In Patients With Copd Including Chronic Bronchitis And Emphysema |
| I-343 |
Use Of Coreg For Severe Heart Failure |
| I-344 |
Acne Vulgaris |
| I-345 |
Treatment Of Posttraumatic Stress Disorder |
| I-346 |
Treatment Of Symptomatic Gastro Esophageal Reflux Disease (Gerd) |
| I-347 |
Treatment Or Prevention Of Bronchospasm In Children 6 Years Of Age And Older With Obstructive Airway Disease |
| I-348 |
Long-Term, Twice-Daily (Morning And Evening) Administration In The Maintenance Treatment Of Bronchospasm Associated With Copd (Including Emphysema And Chronic Bronchitis) |
| I-349 |
Acute Coronary Syndrome |
| I-35 |
Pediatric Contrast Enhancement Of Computed Tomographic Head Imaging |
| I-350 |
Treatment Of Heterozygous Familial Hypercholesterolemia In Adolescent Boys And Girls At Least One Year Postmenarchal, Ages 10 To 17 Years, With A Recommended Dosing Range Of 10 To 40mg Once Daily |
| I-351 |
Prevention Of Postmenopausal Osteoporosis For All Strengths |
| I-352 |
Anticoagulant In Patients With Or At Risk For Heparin-Induced Thrombocytopenia Undergoing Percutaneous Coronary Interventions (Pci) |
| I-353 |
Treatment Of Signs And Symptoms Of Rheumatoid Arthritis |
| I-354 |
Management Of Post Herpetic Neuralgia |
| I-355 |
Premenstrual Dysphoric Disorder |
| I-356 |
Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome |
| I-357 |
Treatment Of Complicated Skin And Skin Structure Infections |
| I-358 |
Treatment Of Panic Disorder |
| I-359 |
Treatment Of Vulvar And Vaginal Atrophy Associated With The Menopause |
| I-36 |
Arthrography Of The Shoulder Joints In Adults |
| I-360 |
Treatment Of Nasal Symptoms Of Seasonal And Perennial Rhinitis In Children Ages Two Up To Age Three |
| I-361 |
Treatment Of Multiple Myeloma And Documented Bone Metastases From Solid Tumors, In Conjunction With Standard Antineoplastic Therapy. Prostate Cancer Should Have Progressed After Treatment With At Least One Hormonal Therapy |
| I-362 |
Treatment Of Panic Disorder, With Or Without Agoraphobia |
| I-363 |
Adjuvant Treatment Of Post Menopausal Women With Hormone Receptor Positive Early Breast Cancer |
| I-364 |
Treatment Of Community-Acquired Pneumonia In Adults |
| I-365 |
Treatment Of Heart Failure (Nyha Class Ii-Iv) In Patients Who Are Intolerant To An Ace Inhibitor |
| I-366 |
Prevention Of Relapse Following Long-Term Treatment Of Major Depressive Disorder |
| I-367 |
Combination Therapy With Thiazolidinedione To Lower Blood Glucose In Pts Whose Hyperglycemia Cannot Be Controlled By Diet/Exercise Plus Monotherapy With Any Of The Following Agents:Metformin,Sulfonylureas,Repaglinide,Or Thiazolidinediones |
| I-368 |
Use Of Glucovance With A Thiazolidinedione When Glycemic Control Is Not Obtained With Glucovance Alone |
| I-369 |
Prevention And Treatment Of Postoperative Nausea And Vomiting |
| I-37 |
Radiography Of The Temporomandibular Joint In Adults |
| I-370 |
Treatment Of Heterozygous Familial Hypercholesterolemia In Children, Ages 8-13 Years, With Recommended Dose Of 20mg Once Daily And In Adolescents, Ages 14-18 With A Recommended Dose Of 40mg Once Daily |
| I-371 |
Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence |
| I-372 |
Nosocomial Pneumonia |
| I-373 |
Treatment Of Type 2 Diabetic Nephropathy |
| I-374 |
Short Term Topical Treatment Of Mild To Moderate Plaque-Type Psoriasis Of Non Scalp Regions |
| I-375 |
First Line Therapy For The Reduction Of Intraocular Pressure In Patients With Open-Angle Glaucoma Or Ocular Hypertension |
| I-376 |
Treatment Of Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Cml) |
| I-377 |
Use Of Bravelle For Multiple Follicular Development (Controlled Ovarian Stimulation) During Assisted Reproductive Technology Cycles In Patients Who Have Previously Received Pituitary Suppression |
| I-378 |
Relief Of Symptoms Of Seasonal Allergic Rhinitis In Adults And Pediatric Patients 2 Years Of Age And Older |
| I-379 |
Use Taxotere In Combination With Cisplatin For The Treatment Of Patients With Unresectable, Locally Advanced Or Metastatic Non-Small Cell Lung Cancer Who Have Not Previously Received Chemotherapy For This Condition |
| I-38 |
Contrast Enhancement Agent To Facilitate Visualization Of Lesions Of The Central Nervous System In Children (2 Years Of Age And Older) |
| I-380 |
To Treat Patients With Schizophrenia Or Schizoaffective Disorder At Risk For Emergent Suicidal Behavior |
| I-381 |
Treatment Of Cold Sores (Herpes Labialis) In Adult And Adolescent Patients 12 Years Of Age And Older |
| I-382 |
For Newly-Diagnosed High Grade Malignant Glioma Patients As An Adjunct To Surgery And Radiation |
| I-383 |
Treatment Of Type 2 Diabetic Nephropathy |
| I-384 |
Use In Combination With Insulin For The Treatment Of Patients With Type 2 Diabetes Mellitus |
| I-385 |
Modification Of The Indication For Community Acquired Pneumonia To Add"Including Penicillin-Resistant Strains, Mic Penicillin>=2mcg/Ml To Streptococcus Pneumoniae |
| I-386 |
Rapamune (Sirolimus) Within An Immunosuppressive Regimen That Would Allow For The Withdrawal Of Cyclosporine 2 To 4 Months After Renal Transplantation In Patients Considered At Low To Moderate Immunologic Risk For Renal Transplant Rejection |
| I-387 |
Adjunctive Therapy Of Partial Seizures In Pediatric Patients Greater That Or Equal To 2 Years Of Age |
| I-388 |
Treatment Of Patients With Left Ventricular Dysfunction Following Myocardial Infarction |
| I-389 |
Supression Of Recurrent Genital Herpes In Hiv-Infected Individuals |
| I-39 |
Treatment Of Acute Myocardial Infarction |
| I-390 |
Use In Pts At High Risk Coronary Events Due To Existing Coronary Heart Disease,Diabetes,Peripheral Vessel Disease,Stroke History,Other Cv Disease To Reduce Risk Total Mortality By Reducing Coronary Death,Reduce Nonfatal Mi & Stroke..... |
| I-391 |
Ablation Of High-Grade Dysplasia In Barrett's Esophagus Patients Who Do Not Undergo Esophagectomy |
| I-392 |
Tx Of Ped Patients W/Ph+ Chronic Phase Cml Disease Recur After Stem Cell Trnsplt Or Resist To Interferon Alpha Therapy.No Controlled Trials Demonstrating A Clinical Benefit Such As Improve In Disease Related Sx Or Increased Survival |
| I-393 |
Chronic Bacterial Prostatitis |
| I-394 |
Use In Patients With Coronary Heart Disease To Reduce The Risk Of Undergoing Coronary Revascularization Procedures |
| I-395 |
To Improve Physical Function |
| I-396 |
Expanded Indication To Include The Assessment Of Ventricular Function In Subjects Being Evaluated For Heart Disease And/Or Ventricular Function |
| I-397 |
Extended Prophylaxis In Patients Undergoing Hip Fracture Surgery |
| I-398 |
Idiopathic Short Stature |
| I-399 |
Treatment Of Candidemia And The Following Candida Infections: Intra-Abdominal Abscesses, Peritonitis And Pleural Space Infections |
| I-4 |
Peripheral Venography (Phlebography) |
| I-40 |
Primary Nocturnal Enuresis |
| I-400 |
Use Of Olanzapine In Combination With Lithium Or Valproate For The Treatment Of Acute Manic Episodes Associated With Bipolar Disorder |
| I-401 |
Longer-Term Efficacy Of Aripiprazole In The Treatment Of Schizophrenia |
| I-402 |
Diabetic Foot Infections Without Concomitant Osteomyelitis |
| I-403 |
Use Of Valtrex In Combination With Safer Sex Practices For The Reduction Of The Risk Of Transmission Of Genital Herpes During Suppresive Therapy Of The Source Partner In A Heterosexual Couple |
| I-404 |
Maintenance Treatment Of Bipolar I Disorder To Delay The Time To Occurrence Of Mood Episodes (Depression, Mania, Hypomania, Mixed Episodes) In Patients Treated For Acute Mood Episodes With Standard Therapy |
| I-405 |
Treatment Of Premenstrual Dysphoric Disorder (Pmdd) Using An Intermittent Dosing Regimen |
| I-406 |
Prevention Of Cytomegalovirus Disease In Kidney, Heart, And Kidney-Pancreas Transplant Patients At High Risk (Donor Cmv Seropositive/Recipient Cmv Seronegative) |
| I-407 |
Improve Survival Of Stable Patients With Left Ventricular Systolic Dysfunction (Ejection Fraction<=40%) And Clinical Evidence Of Congestive Heart Failure After An Acute Myocardial Infarction |
| I-408 |
Stimulation Of Pancreatic Secretions To Facilitate The Indentification Of The Ampulla Of Vater And Accessory Papilla During Endoscopic Retrograde Cholangio-Pancreatography (Ercp) |
| I-409 |
Esophageal Candidiasis |
| I-41 |
Migraine Headache Prophylaxis |
| I-410 |
Use Of Advair Diskus 250/50 For Chronic Obstructive Pulmonary Disease (Copd) Associated With Chronic Bronchitis |
| I-411 |
Expanded Indication For Use In Combination With Antidiabetic Drugs In The Thiazolidinedione Class |
| I-412 |
Monotherapy For The Short Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder |
| I-413 |
Adjunctive Therapy For The Short Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder |
| I-414 |
Prophylaxis Of Deep Vein Thrombosis (Dvt), Which May Lead To Pulmonary Embolism (Pe) In Medical Patients Who Are At Risk For Thromboembolic Complications Due To Severely Restricted Mobility During Acute Illness |
| I-415 |
Severe Hypertension When The Value Of Achieving Prompt Blood Pressure Control Exceeds The Risk Of Initiating Combination Therapy |
| I-416 |
The Use Of Cipro Xr For Complicated Urinary Tract Infections And Acute Uncomplicated Pyelonephritis |
| I-417 |
Use In The Long Term Treatment Of Bipolar I Disorder |
| I-418 |
Adjunctive Therapy W/ Mood Stabilizers (Lithium Or Divalproex) In The Treatment Of Acute Manic Episodes Associated With Bipolar I Disorders |
| I-419 |
Monotherapy In The Treatment Of Acute Manic Episodes Associated With Bipolar I Disorder |
| I-42 |
Herpes Zoster |
| I-420 |
Topical Treatment Of Clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses On The Face Or Scalp In Immunocompetent Adults |
| I-421 |
Treatment Of Complicated Urinary Tract Infections And Pyelonephritis Due To E.Coli For Ped Patients (1-17) Not As First Choice |
| I-422 |
Indicated For The In-Hospital Short-Term (Up To 4 Hours) Reduction In Blood Pressure In Pediatric Patients |
| I-423 |
Acute Treatment Of Migraine Attacks With Or Without Aura In Adults |
| I-424 |
Management Of Secondary Hyperparathyroidism In Patients With Moderate To Severe Chronic Renal Insufficiency Not Yet On Dialysis |
| I-425 |
Floxatin In Combination With Infusional 5-Fluorouracil (5-Fu) And Leucovorin (Lv) For The Treatment Of Patients Previously Untreated For Advanced Colorectal Cancer |
| I-426 |
Treatment Of Acute Pulmonary Embolism When Administered In Conjunction With Warfarin Sodium |
| I-427 |
Treatment Of Acute Deep Vein Thrombosis Without Pulmonary Embolism When Administered In Conjunction With Warfarin Sodium |
| I-428 |
For Use In Combination With Paclitaxel For The First-Line Treatment Of Patients With Metastatic Breast Cancer After Failure Of Prior Anthracycline Containing Adjuvant Chemotherapy Unless Anthracyclines Were Clinically Contraindicated |
| I-429 |
For Use In Combination With Prednisone For The Treatment Of Patients With Androgen Independent (Hormone Refractory) Metastatic Prostate Cancer |
| I-43 |
Herpes Simplex Encephalitis |
| I-430 |
For Use In The Relief Of The Signs And Symptoms Of Rheumatoid Arthritis In Adults |
| I-431 |
Nosocomial Pneumonia And Community-Acquired Pneumonia Caused By Streptococcus Pneumoniae Indication Expanded To Include Multi-Drug Resistant Strains |
| I-432 |
Treatment Of Community Acquired Pneumonia Caused By Multi-Drug Resistant Streptococcus Pneumoniae |
| I-433 |
Treatment Of Biopsy-Confirmed, Primary Superficial Basal Cell Carcinoma In Immunocompetent Adults, With A Maximum Tumor Diameter Of 2.0cm, Located On The Trunk (Excluding Anogenital Skin), Neck, Or Extremities (Excluding Hands And Feet) |
| I-434 |
Prevention Of Cardiovascular Disease In Adult Patients Without Clinically Evident Heart Disease, But With Multiple Risk Factors For Coronary Heart Disease To Reduce Risk Of Mi And Risk For Revascularization Procedures And Angina |
| I-435 |
Chronic Idiopathic Constipation |
| I-436 |
For Use In Combination With Doxorubicin And Cyclophosphamide For The Adjuvant Treatment Of Patients With Operable Node-Positive Breast Cancer |
| I-437 |
Treatment Of Acute Manic And Mixed Episodes Associated With Bipolar Disorder |
| I-438 |
Empirical Therapy For Presumed Fungal Infections In Febrile, Neutropenic Patients |
| I-439 |
Used To Treat Adults With Growth Hormone Deficiency |
| I-44 |
Maintenance Therapy In Healed Duodenal Ulcer Patients At Dose Of 1 Gram Twice Daily |
| I-440 |
For The Replacement Of Endogenous Growth Hormone In Adults With Growth Hormone Deficiency |
| I-441 |
Use Combination With Infusional 5-Fu/Lv For Adjuvant Treatment Stage Iii Colon Cancer Pts Who Have Undergone Complete Resection Primary Tumor-Based On Improvement In Disease Free Survival, No Demonstrated Benefit Overall Survival After 4yrs |
| I-442 |
Used For Candidemia In Nonneutropenic Patients And The Following Candida Infections: Disseminated Infections In Skin & Infections In Abdomen, Kidney, Bladder Wall, And Wounds |
| I-443 |
Treatment Of Nasal Polyps In Patients 18 Years Of Age And Older |
| I-444 |
Use Of Protonix Iv For Injection As Stand Alone Therapy For The Short-Term Treatment Of Patients Having Gastroesophageal Reflux (Gerd) With A History Of Erosive Esophagitis |
| I-445 |
To Improve (Compared To 4.25% Dextrose) Long-Dwell Ultrafiltration And Clearance Of Creatinine And Urea Nitrogen In Patients With High Average Or Greater Transport Characteristics, As Defined Using The Peritoneal Equilibration Test (Pet) |
| I-446 |
Extended Adjuvant Treatment Of Early Breast Cancer In Postmenopausal Women Who Have Received 5 Yrs Adjuvant Tamoxifen Therapy-Effectiveness Based On An Analysis Of Disease Free Survival In Patients Treated For A Median 24 Months |
| I-447 |
Use Of Copegus (Ribavirin) For Treatment Of Chronic Hepatitis C In Adult Patients Coinfected With Hiv In Combination With Pegasys (Peginterferon Alfa-2a) |
| I-448 |
Treatment Of Heart Failure (Nyha Class Ii-Iv And Ejection Fraction <=40%) To Reduce The Risk Of Death From Cardiovascular Causes And To Reduce Hospitalizations For Heart Failure |
| I-449 |
To Improve Wakefulness In Two New Patient Populations With Excessive Sleepiness: Those With Obstructive Sleep Apnea/Hypopnea Syndrome And Those With Shift Work Sleep Disorder |
| I-45 |
Acute Treatment Of Varicella Zoster Virus |
| I-450 |
Treatment Of Patients With Newly Diagnosed High Grade Gliomas Concomitantly With Radiotherapy And Then As Adjuvant Treatment |
| I-451 |
Management Of Endometriosis Associated Pain |
| I-452 |
Expanded Indication To Include Treatment Of Multiple Myeloma Patients Who Have Received At Least 1 Prior Therapy |
| I-453 |
Use In Combination With A Sulfonylurea Plus Metformin When Diet, Exercise And Both Agents Do Not Result In Adequate Glycemic Control (Triple Therapy) |
| I-454 |
Maintenance Of Clinical Remission Of Mild To Moderate Chron's Disease Involving The Ileum And/Or The Ascending Colon For Up To 3 Months |
| I-455 |
Modified Heart Failure Indication To Include Treatment Of Heart Failure In Patients With Left Ventricular Systolic Dysfunction (Nyha Class Ii-Iv; Ejection Fraction Less Than Or Equal To 40% |
| I-456 |
To Reduce Cardiovascular Death And To Reduce Heart Failure Hospitalizations. Includes Additional Information On The Added Effect On These Outcomes When Used With An Ace Inhibitor |
| I-457 |
Treatment Of Patients Undergoing Abdominal Suregery Who Are At Risk For Thromboembolic Compliations |
| I-458 |
Use Of Bivalirudin For Injection With Provisional Use Of Glycoprotein Iib/Iia Inhibitor (Gpi) As Listed In The Clinical Trials Replace-2 Section For Use As An Anticoagulant In Patients Undergoing Percutaneous Coronary Intervention (Pci) |
| I-459 |
Non-Dialysis Dependent Chronic Kidney Disease (Ndd-Ckd) Patients Receiving Or Not Receiving An Erythropoietin |
| I-46 |
Use In Pediatric Computed Tomographic Head And Body Imaging |
| I-460 |
Treatment Of Diarrhea Caused By Cryptosporidium Parvum In Non-Hiv Infected Patients 12 Years Of Age And Older |
| I-461 |
Use As A Single Agent For Adjuvant Treatment In Patients With Dukes' C Colon Cancer Who Have Undergone Complete Resection Of The Primary Tumor When Treatment With Fluoropyrimidine Therapy Alone Is Preferred |
| I-462 |
Long Term Treatment Of Idiopathic Short Stature |
| I-463 |
Treatment Of Patients Post Myocardial Infarction |
| I-464 |
Treatment Of Moderate To Severe Primary Restless Legs Syndrome |
| I-465 |
Perennial Allergic Rhinitis In Adults And Pediatric Patients 6 Months Of Age And Older |
| I-466 |
For Relief Of The Signs And Symptoms Of Ankylosing Spondylitis |
| I-467 |
Use Of Topiramate As Initial Monotherapy In Patients 10 Years Of Age And Older With Partial Onset Or Primary Generalized Tonic Clonic Seizures |
| I-468 |
Use In Patients With Stable Coronary Artery Disease To Reduse The Risk Of Cardiovascular Mortality Or Non-Fatal Myocardial Infection |
| I-469 |
Relief Of The Signs And Symptoms Of Pauciarticular Or Polyarticular Course Juvenile Rheumatoid Arthritis In Patients 2 Years Of Age And Older |
| I-47 |
Treatment Of Pediatric Patients With Symptomatic Human Immunodeficiency Virus (Hiv) Disease |
| I-470 |
Diabetic Peripheral Neuropathic Pain |
| I-471 |
Indicated To Reduce The Risk Of Myocardial Infarction And Stroke In Patients With Type 2 Diabetes And Without Clinically Evident Coronary Heart Disease But With Multiple Risk Factors For Coronary Heart Disease |
| I-472 |
Use In Patients With Angiographically Documented Coronary Artery Disease |
| I-473 |
Use In Combination With Gemcitabine For The First Line Treatment Of Patients With Locally Advanced Unresectable Or Metastatic Pancreatic Cancer |
| I-474 |
Treatment Of Iron Deficiency Anemia In Peritoneal Dialysis Dependant Chronic Kidney Disease In Patients Recieving An Erythropoietin |
| I-475 |
Prevention Of Nausea And Vomitting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy |
| I-476 |
Treatment Of Diabetic Foot Infections Without Osteomyelitis |
| I-477 |
Treatment Of Complicated Skin And Skin Structure Infections Caused By Methicillin Susceptible Staphylococcus Aureus, Escherichia Coli, Klebsiella Pneumoniae, Or Enterobacter Cloacae |
| I-478 |
For Use As Adjunctive Therapy In The Treatment Of Partial Seizures In Children With Epilepsy Aged 2-4 Years |
| I-479 |
Treatment Of Complicated Intra-Abdominal Infections Caused By E.Coli, B. Fragilis, S.Anginosus, S.Constellatus, E. Faecalis, P. Mirabilis, C. Perfringens, B. Thetaiotaomicron Or Peptostreptococcus Species |
| I-48 |
Pediatric Angiocardiography |
| I-480 |
Prophylaxis Of Influenza For Patients Between 1-12 Years Of Age |
| I-481 |
Indicated For The Adjuvant Treatment Of Postmenopausal Women With Hormone Receptor Positive Early Breast Cancer |
| I-482 |
Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder With Or Without Psychotic Features |
| I-483 |
Prevention Of Postmenopausal Osteoporosis |
| I-484 |
For The Risk Reduction Of Nsaid-Associated Gastric Ulcers |
| I-485 |
Treatment Of Postoperative Inflammation And Reduction Of Ocular Pain In Patients Who Have Undergone Cataract Extraction |
| I-486 |
Angiomax Is Indicated For Patients With, Or At Risk Of, Hit/Hitts Undergoing Pci |
| I-487 |
Indicated For The Relief Of The Infammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses In Patients 12 Yrs Of Age Or Older |
| I-488 |
Maintenance Therapy In Bipolar I Disorder |
| I-489 |
For Use In Pediatric Patients With Type I Diabetes |
| I-49 |
Treatment Of Travelers' Diarrhea Due To Susceptible Strains Of Enterotoxigenic Escherichia Coli |
| I-490 |
For Use In Combination With Cisplatin And Fluorouracil For The Treatment Of Patients With Advanced Gastric Adenocarcinoma, Including Adenocarcinoma Of Gastroesophageal Junction, Who Have Not Received Prior Chemotherapy For Advanced Disease |
| I-491 |
Influenza Prophylaxis |
| I-492 |
Monotherapy In The Treatment Of Acute Manic Or Mixed Episodes In Bipolar I Disorder, With Or Without Psychotic Features |
| I-493 |
Administered In Combination With Fenofibrate, As Adjunctive Therapy To Diet For The Reduction Of Elevated Total-C, Ldl-C, Apo B, And Non-Hdl-C In Patients With Mixed Hyperlipidemia |
| I-494 |
Clinical Data In Support Of Avandamet As An Adjunct To Diet And Exercise To Improve Glycemic Control In Patients With Type 2 Diabetes Mellitus When Treatment With Dual Rosiglitazone And Metformin Therapy Is Appropriate |
| I-495 |
Adjuvant Tx Of Postmenopausal Women With Estrogen-Receptor Positive Early Breast Cancer Who Have Received 2 To 3 Yrs Of Tamoxifen And Are Switched To Aromasin For Completion Of A Total Of 5 Consecutive Yrs Of Adjuvant Hormonal Therapy |
| I-496 |
Long Term Treatment Of Growth Failure Associated With Turner Syndrome In Patients Who Have Open Epiphyses |
| I-497 |
Prevention Of Seasonal Major Depressive Episodes In Patients With Seasonal Affective Disorder |
| I-498 |
Prevention Of Postoperative Nausea And Vomiting |
| I-499 |
Use Of Gemzar In Combination With Carboplatin For The Treatment Of Patients With Advanced Ovarian Cancer That Has Relapsed At Least 6 Months After Completion Of Platinum-Based Therapy |
| I-5 |
Hysterosalpingography |
| I-50 |
For Use In Women With Axillary Node-Negative Breast Cancer |
| I-500 |
For Use In Combination With Dexamethasone For The Treatment Of Multiple Myeloma Patients Who Have Received At Least One Prior Therapy |
| I-501 |
Treatment Of Recurrent Herpes Labialis (Cold Sores) In Immunocompetant Patients With A Single Dose Of Famciclovir 1500 Mg. |
| I-502 |
For Pts With St-Segment Elevation Acute Myocardial Infarction, Plavix To Reduce Rate Of Death From Any Cause And The Rate Of A Combined Endpoint Of Death, Reinfarction Or Stroke. Not Known To Pertain To Pts Who Receive Primary Angioplasty |
| I-503 |
Treatment Of Major Depressive Episodes Associated With Bipolar Disorder |
| I-504 |
Treatment Of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome |
| I-505 |
Treatment Of Staphylococcus Aureus Bloodstream Infections (Bacteremia), Including Those With Right Sided Infective Endocarditis, Caused By Methicillin-Susceptible And Methicillin-Resistant Isolates |
| I-506 |
Adjunctive Therapy Of Myoclonic Seizures In Adults And Adolescents Age 12 And Over With Juvenile Myoclonic Epilepsy |
| I-507 |
Adjunct To Diet To Reduce Total-C, Ldl-C And Apo B Levels In Adolescent Boys And Girls Who Are At Least One Year Post-Menarche, 10-16 Years Of Age, With Heterozygous Familial Hypercholesterolemia |
| I-508 |
Premenstrual Dysphonic Disorder |
| I-509 |
Treatment Of Irratability Associated With Autistic Disorder |
| I-51 |
Treatment Of Primary Dysmenorrhea And For The Treatment Of Idiopathic Heavy Menstrual Blood Loss |
| I-510 |
Adult Dermafibrosarcoma Protuberans (Dfsp) |
| I-511 |
Adult Myelodysplastic Syndrome/Myeloproliferative Diseases (Mds/Mdp) |
| I-512 |
Adult Ph+ Acute Lymphoblastic Leukemia (All) Monotherapy |
| I-513 |
Adult Aggressive Systemic Mastocytosis (Asm) |
| I-514 |
Adult Hypereosinophilic Syndrome/Chronic Eosinophilic Leukemia (Hes/Cel) |
| I-515 |
Prophylaxis Of Surgical Site Infection Following Elective Colorectal Surgery |
| I-516 |
Primary Generalized Tonic Clonic Seizures In Adults And Pediatric Patients 2 Years Of Age And Older |
| I-517 |
Treatment Of Moderate To Severe Primary Restless Leg Syndrome (Rls) |
| I-518 |
Treatment Of Short Stature Or Growth Failure In Children With Shox (Short Stature Homeobox Containing Gene) Deficiency Whose Epiphyses Are Not Closed |
| I-519 |
Use Of Taxotere (Docetaxel) Injection Concentrate In Combination With Cisplatin And Fluorouracil For The Induction Of Patients With Inoperable Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (Scchn) |
| I-52 |
Pediatric Excretory Urography |
| I-520 |
Use Of Exenatide In Patients With Type 2 Diabetes Mellitus Who Are Using A Thiazolidinedione Alone Or In Combination With Metformin But Have Not Achieved Adequate Glycemic Control |
| I-521 |
Treatment Of Patients With Mantle Cell Lymphoma Who Have Received At Least 1 Year Prior Therapy |
| I-522 |
Treatment Of Moderate Acne Vulgaris In Women At Least 14 Yrs Of Age, Who Have No Known Contraindications To Oral Contraceptive Therapy, And Have Achieved Menarche, If The Patient Desires An Oral Contraceptive For Birth Control. |
| I-523 |
Use In Adult Patients With Clinically Evident Coronary Heart Disease To Reduce The Risk Of Nonfatal Myocardial Infarction, Fatal And Nonfatal Stroke, Angina, Revascularization Procedures And Hospitalization For Congestive Heart Failure |
| I-524 |
Generalized Anxiety Disorder (Gad) |
| I-525 |
Use Of 0.5mg/0.1mg For Prevention Of Post-Menopausal Osteoporosis |
| I-526 |
Treatment Of Hyponatremia In Hospitalized Patients |
| I-527 |
Adjunctive Therapy In The Treatment Of Primary Generalized Tonic-Clonic Seizures In Adults And Children 6 Years Of Age And Older With Idiopathic Generalized Epilepsy |
| I-528 |
Treatment Of Moderate To Severe Vaginal Dryness And Pain With Intercourse, Symptoms Of Vulvar And Vaginal Atrophy Associated With Menopause |
| I-529 |
Treatment Of Dementia Of The Alzheimer's Type In Patients With Severe Alzheimer's Disease |
| I-53 |
Treatment Of Panic Disorder, With Or Without Agoraphobia |
| I-530 |
Prevention Of Exercise-Induced Bronchoconstriction In Patients 15 Years Of Age And Older |
| I-531 |
Maintenance Treatment Of Schizophrenia |
| I-532 |
Treatment Of Bacterial Vaginosis In Non-Pregnant Females |
| I-533 |
Acute St-Segment Elevation Myocardial Infarction (Stemi) |
| I-534 |
Extended Treatment Of Symptomatic Venous Thromboembolism (Vte) And/Or Pulmonary Embolism To Reduce The Reccurence Of Vte In Patients With Cancer |
| I-535 |
Management Of Fibromyalgia |
| I-536 |
For The Treatment Of Short Stature In Children With Noonan Syndrome |
| I-537 |
Long Term Treatment Of Panic Disorder |
| I-538 |
Short Term Treatment Of Panic Disorder |
| I-539 |
Reduction In Risk Of Invasive Breast Cancer In Postmenopausal Women With Osteoporosis Or At High Risk For Invasive Breast Cancer |
| I-54 |
Renal Concentration Capacity Test |
| I-540 |
Treatment Of Schizophrenia In Adolescents Ages 13-17 |
| I-541 |
Treatment Of Bipolar I Disorder In Children Ages 10-12 And Adolescents Ages 13-17 |
| I-542 |
Expansion Of Patient Population For Head And Neck Cancer From "Inoperable" Patients To All Patients |
| I-543 |
Use In Combination With Cisplatin And Fluorouracil For The Induction Treatment Of Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (Scchn) |
| I-544 |
Adjunctive Therapy Of Myoclonic Seizures In Adults And Adolescents Age 16 And Over With Juvenile Myoclonic Epilepsy |
| I-545 |
Adjunctive Treatment To Treat Patients With Major Depressive Disorder |
| I-546 |
Treatment Of Unresectable Hepatocellular Carcinoma |
| I-547 |
Adjunctive Therapy To Diet To Slow The Progression Of Artherosclerosis In Adult Patients As Part Of A Treatment Strategy To Lower Total-C And Ldl-C To Target Levels |
| I-548 |
Seasonal Allergic Rhinitis In Patients 6 Through Less Than 12 Years Of Age |
| I-549 |
Use Of Avalide Tablets As Initial Therapy In Patients Who Are Likely To Need Multiple Drugs To Achieve Their Blood Pressure Goals |
| I-55 |
Hypertension |
| I-550 |
Treatment Of Hypertension In Pediatric Patients 6-16 Years Of Age |
| I-551 |
Treatment Of Short Stature In Children With Turner's Syndrome |
| I-552 |
Adjunctive Treatment For Radioiodine Ablation Of Thyroid Tissue Remnants In Patients Who Have Undergone Thyroidectomy For Well-Differentiated Thyroid Cancer And Who Do Not Have Evidence Of Metastatic Thyroid Cancer |
| I-553 |
For Use As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus |
| I-554 |
Treatment Of Patients With Candidemia, Acute Disseminated Candidiasis, Candida Peritonis And Abscesses |
| I-555 |
Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder In Pediatric Patients Aged 10-17 Years |
| I-556 |
Prevention Of Post Operative Nausea And Vomiting For Up To 24 Hours Following Surgery |
| I-557 |
Use Of Amitiza (Lubiprostone) 8 Mcg Twice Daily For Treatment Of Irritable Bowel Syndrome With Constipation In Women Greater Than Or Equal To 18 Years Old |
| I-558 |
Maintenance Treatment Of Airflow Obstruction And Reducing Exacerations In Patients With Chronic Obstructive Pulmonary Disease (Copd) Including Chronic Bronchitis And Emphysema |
| I-559 |
Adjunctive Therapy Added To Lithium Or Valproate In Short Term Treatment Of Bipolar Disorder, Manic Or Mixed |
| I-56 |
Erosive Gastroesophageal Reflux Disease |
| I-560 |
Maintenance Treatment For Bipolar I Disorder, As Adjunctive Therapy To Lithium Or Divalproex |
| I-561 |
Long-Term Treatment Of Social Anxiety Disorder |
| I-562 |
Maintenance Treatment Of Attention-Deficit Disorder (Adhd) In Children And Adolescents |
| I-563 |
Adjunctive Therapy In The Treatment Of Primary Generalized Tonic-Clonic Siezures In Adults And Children 16 Years Of Age And Older With Idiopathic Generalized Epilepsy |
| I-564 |
Treatment Of Patients With Multiple Myeloma |
| I-565 |
Use Of Dutasteride In Combination With Tamsulosin For The Treatment Of Symptomatic Benign Prostatic Hyperplasia (Bph) |
| I-566 |
Management Of Fibromyalgia |
| I-567 |
Initial Therapy In Patients Likely To Need Multiple Drugs To Achieve Their Blood Pressure Goals |
| I-568 |
Use Of Aptivus, Co-Administered W/Ritonavir, For Combination Antiretroviral Treatment Of Hiv-1 Infected Ped (Age 2-18 Yrs) Patients Who Are Treatment-Experienced And Infected W/Hiv-1 Strains Resistant To More Than One Protease Inhibitor |
| I-569 |
Treatment Of Chronic Hepatitis B |
| I-57 |
Short-Term Treatment Of Active Duodenal Ulcer |
| I-570 |
Treatment Of Chicken Pox In Immunocompetent Pediatric Patients 2 To <18 Years Of Age |
| I-571 |
Non-Small Cell Lung Cancer In Combination With Cisplatin And As Single Agent For Nonsqaumous Non-Small Cell Lung Cancer |
| I-572 |
Treatment Of Growth Failure In Children Born Small For Gestational Age (Sga) With No Catch-Up By Age 2-4 Yrs. |
| I-573 |
To Treat Patients With Primary Dysbetalipoproteinemia (Fredickson Type Iii Hyperlipoproteinemia) As An Adjunct To Diet |
| I-574 |
Monotherapy In The Treatment Of Bipolar Depression |
| I-575 |
Monotherapy In The Treatment Of Bipolar Mania |
| I-576 |
Adjunctive Therapy In The Treatment Of Bipolar Mania |
| I-577 |
Sedation Of Non-Intubated Patients Prior To And/Or During Surgical And Other Procudures |
| I-578 |
Expansion Of Indication To Include Treatment Of Hiv In Treatment Naive Adults |
| I-579 |
Treatment Of Moderate To Severe Dyspareunia, A Symptom Of Vulvar And Vaginal Atrophy, Due To Menopause And New Twice Weekly Dosing Regimen For This Indication |
| I-58 |
Initial Treatment Of Advanced Ovarian Carcinoma In Combination With Other Approved Chemotherapeutic Agents |
| I-580 |
Indolent B-Cell Non-Hodgkins Lymphoma (Nhl) That Has Progressed During Or Within Six Months Of Treatment With Rituximab Or A Rituximab Containing Regimen |
| I-581 |
Treatment To Increase Bone Mass In Men With Osteoporosis |
| I-582 |
Treatment Of Chronic Obstructive Pulmonary Disease |
| I-583 |
Adjuvant Treatment Of Adult Patients Following Complete Gross Resection Of Kit (Cd117) Positive Gastointestinal Stromal Tumors (Gist) |
| I-584 |
Treatment And Prevention Of Glucocorticoid-Induced Osteoporosis In Patients Expected To Be On Glucocorticoids For At Least 12 Months |
| I-585 |
Treatment Of Short Stature In Pediatric Patients Small For Gestational Age Who Do Not Manifest Catch Up Growth By Age 2 To 4 Years |
| I-586 |
Community Acquired Bacterial Pneumonia |
| I-587 |
Additional Pathogens To Complicated Skin And Skin Structure Infections Indication |
| I-588 |
Additional Pathogens To Complicated Intra-Abdominal Infections Indication |
| I-589 |
Treatment Of Treatment Resistant Depression (Trd) In Combination With Olanzapine |
| I-59 |
Endoscopically Diagnosed Esophagitis, Including Erosive And Ulcerative Esophagitis, And Associated Heartburn Due To Gastroesophageal Reflux Disease |
| I-590 |
Acute Treatment Of Depressive Episodes Associated With Bipolar Disorder (In Combination With Olanzapine) |
| I-591 |
Treatment Of Treatment Resistant Depression (Trd) In Combination With Fluoxetine |
| I-592 |
Acute Treatment Of Depressive Episodes Associated With Bipolar Disorder (In Combination With Fluoxetine) |
| I-593 |
Treatment Of Treatment Resistant Depression (Trd) |
| I-594 |
Indication Expanded To Include Patients Who Have Experienced A First Clinical Episode And Have Mri Features Consistent With Multiple Sclerosis |
| I-595 |
Prevention Of Osteoporosis In Postmenopausal Women |
| I-596 |
Use As Adjunctive Therapy With Lithium Or Valproate For The Maintenance Treatment Of Bipolar I Disorder |
| I-597 |
Monotherapy For The Maintenance Treatment Of Bipolar I Disorder |
| I-598 |
Treatment Of Pulmonary Arterial Hypertension Indication Expanded To Include Delay In Clinical Worsening |
| I-599 |
Prevention And Treatment Of Secondary Hyperparathyroidism Associated With Chronic Kidney Disease (Ckd) Stage 5 In Patients On Hemodialysis Or Peritoneal Dialysis |
| I-6 |
Treatment Of Juvenile Arthritis |
| I-60 |
Single Application Treatment Of Head Lice In Children Two Months To Two Years In Age |
| I-600 |
For Use As Initial Therapy In Patients Who Are Likely To Need Multiple Drugs To Achieve Their Blood Pressure Goals |
| I-601 |
Maintenance Treatment In Patients With Advanced Or Metastatic Nonsquamous Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Four Cycles Of Platinum-Based First Line Chemotherapy |
| I-602 |
Treatment Of Men And Women With Osteoporosis Associated With Sustained Systemic Glucocorticoid Therapy At High Risk For Fracture |
| I-603 |
Gout Flares |
| I-604 |
Prevention Of Cmv Disease In Kidney And Heart Transplant Patients 4 Months To 16 Years At High Risk |
| I-605 |
Adjunct To Mood Stabilizers And/Or Antidepressants For Schizoaffective Disorder |
| I-606 |
Treatment Of Schizoaffective Disorder As Monotherapy |
| I-607 |
Indication Expanded To Include Treatment Of Pulmonary Artenal Hypertension (Who Group I) In Patients With Class Ii Symptoms |
| I-608 |
Reduce Ldl-C Levels In Boys And Postmenarchal Girls, 10 To 17 Years Of Age, With Heterozygous Familial Hypercholesterolemia As Monotherapy Or In Combination With A Statin After Failing An Adequate Trial Of Diet Therapy |
| I-61 |
Female Androgenetic Alopecia |
| I-610 |
Treatment Of Heavy Menstrual Bleeding For Women Who Choose To Use Intrauterine Contraception As Their Method Of Contraception |
| I-611 |
Treatment Of Heterozygous Familial Hypercholesterolemia In Adolescent Boys And Postmenarchal Girls, Ages 10 To 17 Years, With A Recommendation Dosing Range Of 5 To 20 Mg Once Daily |
| I-612 |
Micardis 80 Mg For Reduction Of The Risk Of Myocardial Infarction, Stroke, Or Death From Cardiovascular Causes In Patients 55 Years Of Age Or Older At High Risk Of Developing Major Cardiovascular Events Who Are Unable To Take Ace Inhibitors |
| I-613 |
Mild To Moderate Atopic Dermatitis In Patients 3 Months Of Age To Less Than 18 Years Of Age |
| I-614 |
Short Term Treatment Of Erosive Esophagitis Associated With Gerd In Pediatric Patients Ages Five Years And Older |
| I-615 |
Maintenance Treatment Of Bipolar Disorder As An Adjunct To Lithium Or Valproate |
| I-616 |
Treatment Of Irritability Associated With Autistic Disorder In Pediatric Patients Ages 6-17 Years Of Age |
| I-617 |
Maintenance Of Generalized Anxiety Disorder (Gad) |
| I-618 |
Adjunctive Therapy In The Treatment Of Major Depressive Disorder (Mdd) |
| I-619 |
Intravenous Contrast Enhanced Computer Tomography Of The Head And Body |
| I-62 |
Prevention And Treatment Of Postmenopausal Osteoporosis |
| I-620 |
For Use In Combination With Letrozole For The Treatment Of Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer That Overexpresses The Her2 Receptor For Whom Hormonal Therapy Is Indicated |
| I-621 |
Primary Prevention Of Cardiovascular Disease, Based On The Results Of Justification For The Use Of Statins In Primary Prevention; An Intervention Trial Evaluating Rosuvastatin (Jupiter) |
| I-622 |
Adjunctive Therapy For Primary Generalized Tonic-Clonic Seizures In Patients Thirteen Years Of Age And Older |
| I-623 |
Treatment Of Signs And Symptoms Of Advanced Idiopathic Parkinson's Disease |
| I-624 |
Maintenance Treatment Of Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Four Cycles Of Platinum-Based First-Line Chemotherapy |
| I-625 |
Pancreatic Insufficiency Due To Chronic Pancreatitis And Pancreatectomy |
| I-626 |
Relief Of Nasal Congestion Associated With Seasonal Allergic Rhinitis In Adults And Pediatric Patents 2 Years Of Age And Older |
| I-627 |
Treatment Of Newly Diagnosed Adult Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph & Cml) In Chronic Phase. |
| I-628 |
Maintenance Treatment Of Schizophrenia In Adults |
| I-629 |
Adjunctive Therapy With Either Lithium Or Valproate For The Acute Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder |
| I-63 |
Once Daily Treatment As Initial Therapy In The Treatment Of Hypertension |
| I-630 |
Treatment Of Patients With Subependymal Giant Cell Astrocytoma (Sega) Associated With Tuberous Sclerosis (Ts) Who Require Therapeutic Intervention But Are Not Candidates For Curative Surgical Resection. |
| I-631 |
Prevention Of Relapse To Opioid Dependence Following Opioid Detoxification |
| I-632 |
Management Of Chronic Musculoskeletal Pain |
| I-633 |
Maintenance Treatment Of Bipolar I Disorder As An Adjunct To Lithium Or Valproate |
| I-634 |
Treatment Of Severe Hypercalcemia In Patients With Primary Hyperparathyroidism Who Are Unable To Undergo Parathyroidectomy |
| I-635 |
Adjunctive Treatment With Long-Acting Oral Psychostimulants For The Treatment Of Attention Deficit Hyperactivity Disorder (Adhd) |
| I-636 |
Treatment Of External Genital And Perianal Warts/Condyloma Acuminata In Patients 12 Years Or Older |
| I-637 |
Use In Combination Chemotherapy With 5-Fluorouracil In The Palliative Treatment Of Patients With Advanced Metastatic Colorectal Cancer |
| I-638 |
For Patients With Progressive Neuroendocrine Tumors Of Pancreatic Origin (Pnet) That Are Unresectable, Locally Advanced, Or Metastatic. |
| I-639 |
Treatment Of Progressive, Well-Differentiated Pancreatic Neuroendocrine Tumors In Patients With Unresectable, Locally Advanced, Or Metastatic Disease |
| I-64 |
Prevention Of Supraventricular Tachycardias |
| I-640 |
Maintenance Of Remission Of Ulcerative Colitis |
| I-641 |
Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (Bph) |
| I-642 |
Treatment Of Erectile Dysfunction (Ed) And The Signs And Symptoms Of Benign Prostatic Hyperplasia (Bph) |
| I-643 |
Reduce The Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation. |
| I-644 |
Monotherapy In Patients 13 Years Of Age And Older With Partial Seizures Who Are Receiving Therapy With A Single Antiepileptic Drug (Aed) |
| I-645 |
Maintenance Treatment Of Attention Deficit Hyperactivity Disorder (Adhd) In Adults |
| I-646 |
Signs And Symptoms Of Advanced Parkinson's Disease (Apd) |
| I-647 |
Signs And Symptoms Of Moderate To Severe Primary Restless Legs Syndrome (Rls) |
| I-648 |
Treatment Of Heavy Menstrual Bleeding In Women Without Organic Pathology Who Choose To Use An Oral Contraceptive As Their Method Of Contraception |
| I-649 |
Treatment Of Patients With Advanced Soft Tissue Sarcoma (Sts) Who Have Received Prior Chemotherapy |
| I-65 |
Prevention Of Upper Gastrointestinal Bleeding In Critically Ill Patients |
| I-650 |
Treatment Of Adults With Renal Angiomyolipoma And Tuberous Sclerosis Complex (Tsc), Not Requiring Immediate Surgery |
| I-651 |
Management Of Neuropathic Pain Associated With Spinal Cord Injury |
| I-652 |
Management Of Postherpetic Neuralgia |
| I-653 |
Treatment Of Endogenous Anterior Uveitis |
| I-654 |
Magnetic Resonance Angiography (Mra) To Evaluate Adults With Known Or Suspected Renal Or Aorto-Ilio-Femoral Occlusive Vascular Disease |
| I-655 |
Treatment Of Postmenopausal Women With Advanced Hormone Receptor-Positive,Her2-Negative Breast Cancer (Advanced Hr+Bc) In Combination With Exemestane, After Failure Of Treatment With Letrozole Or Anastrozole |
| I-66 |
Uncomplicated Gonorrhea |
| I-67 |
Treatment Of Acute Asthmatic Attacks In Children Six Years Of Age And Older |
| I-68 |
Central Precocious Puberty |
| I-69 |
Short Term Treatment Of Patients With Symptoms Of Gastroesophageal Reflux Disease (Gerd), And For The Short Term Treatment Of Esophagitis Due To Gerd Including Ulcerative Disease Diagnosed By Endoscopy |
| I-7 |
Biopsy Proven Minimal Change Nephrotic Syndrome In Children |
| I-70 |
Use In Combination With 5-Fluorouracil To Prolong Survival In The Palliative Treatment Of Patients With Advanced Colorectal Cancer |
| I-71 |
Varicella Infections (Chickenpox) |
| I-72 |
Prevention Of Cmv Disease In Transplant Patients At Risk For Cmv Disease |
| I-73 |
Initiate And Maintain Monitored Anesthesia Care (Mac) Sedation During Diagnostic Procedures |
| I-74 |
Intravenous Digital Subtraction Angiography |
| I-75 |
Treatment Of Endoscopically Diagnosed Erosive Esophagitis |
| I-76 |
Prevention Of Osteoporosis |
| I-77 |
Dermal Infections-Tinea Pedis, Tinea Corporis, Tinea Cruris Due To Epidermophyton Floccosum |
| I-78 |
Contrast Enhanced Computed Tomographic Imaging Of The Head And Body And Intravenous Excretory Urography |
| I-79 |
Management Of Chronic Stable Angina And Angina Due To Coronary Artery Spasm |
| I-8 |
Adult Intravenous Contrast-Enhanced Computed Tomography Of The Head And Body |
| I-80 |
Diagnosis And Localization Of Ischemia And Coronary Heart Disease |
| I-81 |
Prophylaxis In Designated Immunocompromised Conditions To Reduce The Incidence Of Oropharyngeal Candidiasis |
| I-82 |
Treatment Of Travelers' Diarrhea |
| I-83 |
Angiocardiography, Contrast Enhanced Computed Tomographic Imaging Of The Head And Body, And Intravenous Excretory Urography In Children |
| I-84 |
Intraoperative And Postoperative Tachycardia And/Or Hypertension |
| I-85 |
Treatment Of Anorexia Associated With Weight Loss In Patients With Aids |
| I-86 |
Treatment Of Secondary Carnitine Deficiency |
| I-87 |
Renal Imaging Agent For Use In Children |
| I-88 |
Management Of Endometriosis |
| I-89 |
Epidural Use In Labor And Delivery As An Analgesic Adjunct To Bupivacaine |
| I-9 |
Prevention Of Postoperative Nausea And Vomiting |
| I-90 |
Intensive Care Unit Sedation |
| I-91 |
Monotherapy Use For Hypertension |
| I-92 |
Adjunctive Therapy In The Management Of Heart Failure |
| I-93 |
Prevention Of Exercise-Induced Bronchospasm In Children Ages 4-11 Years |
| I-94 |
Use With Mri In Adults To Provide Contrast Enhancement And Facilitate Visualization Of Lesions In The Body [Excluding The Heart] |
| I-95 |
Treatment Of Left Ventricular Dysfunction Following Myocardial Infarction |
| I-96 |
Treatment Of Symptomatic Benign Prostatic Hyperplasia |
| I-97 |
Oral Or Rectal Use In Children For The Examination Of The Gastrointestinal Tract |
| I-98 |
Treatment Of Children Who Have Growth Failure Associated With Chronic Renal Insufficiency |
| I-99 |
Pediatric Anesthesia In Children 3 Years And Older |
| M |
Miscellaneous Exclusivity Codes (See Individual References) |
| M-1 |
Information Regarding Superiority Claim Over Ranitidine For Day And Night Heartburn Added To Clinical Studies Section |
| M-10 |
Information Regarding Maintenance Of An Antidepressant Effect Up To 1 Year Of Dosing |
| M-100 |
Information Added To Label Based Upon Completed Clinical Trial Reports |
| M-101 |
Inclusion Of Data From An Additional 19 Subjects With Hypercalcemia From Parathyroid Carcinoma To The Information Currently Presented In The Label |
| M-102 |
Information From Pediatric Study Report Ml16633, "Intravenous Granisetron (Kytril) In The Prevention Of Post-Operative Nausea And Vomiting (Ponv) In Pediatric Subjects Undergoing Tonsillectomy Or Adenotonsillectomy." |
| M-103 |
Safety, Efficacy And Pharmacokinetic Info For Faslodex In The Pediatric Population, Specifically For Girls With Progressive Precocious Puberty Associated With Mccune-Albright Syndrome Added To The Pediatric Use Section Of The Labeling |
| M-104 |
Information Added To Dosing And Administration Regarding A 26 Week Study |
| M-105 |
New Language Added To Clinical Studies Regarding Use In Smokers With Cardiovascular Disease, Chronic Obstructive Pulmonary Disease, And Use According To An Alternative Set Of Directions For Setting A Quit Date |
| M-106 |
Addition Of The T1-Weighted Gd-Enhanced Lesion Efficacy Variable In The Clinical Studies Section 14 Of The Package Insert |
| M-107 |
Information To The Clinical Studies Section Of The Lupron Depot-Ped,1-Month,Based Upon The Phase 3/4 Completed Clinical Study Report For Study M90-516, Entitled "Study Of Lupron Depot In The Treatment Of Central Precocious Puberty". |
| M-108 |
Changes Are Based On Results From Study Cv181057 |
| M-109 |
Changes To The Package Insert To Reflect The Results Of The Study Of Heart And Renal Protection (Sharp) Trial |
| M-11 |
Use For Long-Term Treatment Of Posttraumatic Stress Disorder |
| M-110 |
Changes To The Package Insert To Reflect The Results Of The Study Of Heart And Renal Protection (Sharp) Trial |
| M-111 |
Labeling Changes Based On Study Hw80-Ew-Gwci Entitled A Placebo And Positive Controlled Study Of The Electrophysiological Effects Of A Single 10 Mcg Dose Of Exenatide On The 12 Lead Electrocardiogram Qt Interval In Healthy Subjects |
| M-112 |
Revisions To The Pediatric Use Section Of The Package Insert To Add Information From A Pediatric Study In Patients Aged 12 Years To Less Than 18 Years Of Age With Recurrent Herpes Labialis |
| M-113 |
Labeling Changes Based On Study H80-Us-Gwco Entitled A Randomized Trial Comparing Exenatide With Placebo In Subjects With Type 2 Diabetes On Insulin Glargine With Or Without Oral Antihyperglycemic Medications |
| M-114 |
Changes In Section 14 Of The Package Insert To Include Data From The Switchmrk Studies (Switch Of Suppressed Subjects From Lopinavir/Ritonavir To Raltegravir) |
| M-115 |
Revisions To The Pi Based On Results From Study Nn2211-1842, Entitled The Effect Of Insulin Detemir In Combination With Liraglutide And Metformin Compared To Liraglutide And Metformin In Subjects With Type 2 Diabetes |
| M-116 |
Labeling Changes Based On Results From Clinical Study 01-06-Tl-Opimet-008 |
| M-117 |
Addition Of Results Of Pediatric Trial To Label |
| M-12 |
New Language For Pediatric Use |
| M-13 |
Information From Pediatric Studies Added To Clinical Pharmacology, Precautions, And Dosage And Administration |
| M-14 |
Additional Clinical Trial Information Added To Pediatric Use Subsection |
| M-15 |
Longer Term Efficacy Information For Risperidone In The Treatment Of Schizophrenia |
| M-16 |
Change In Wording Of The Pediatric Section Of The Package Insert |
| M-17 |
Information Regarding Use Of Ultane In Pediatric Patients With Congenital Heart Disease |
| M-18 |
Information Denoting The Efficacy Of Remeron In Maintaining A Response In Patients With Major Depressive Disorder (Mdd) |
| M-19 |
Information Regarding Use In Pediatric Patients Two Years Of Age And Older |
| M-2 |
Approval For Addtion To Clinical Pharmacology Section Of The Label Regarding (1) Improvement In Bone Mineral Density In Childhood-Onset Adult Growth Hormone Deficient Patients And (2) Increases In Serum Alkaline Phosphatase |
| M-20 |
Labeling Revisions Related To Mccune Albright Syndrome |
| M-21 |
Comparison Data On The Antihypertensive Effects Of Atacand And Cozaar |
| M-22 |
Change In Time To Onset Of Action |
| M-23 |
Information Regarding Elimination Added To Clinical Pharmacology, Study Results In Patients With Hepatic And Renal Impairment |
| M-24 |
Information On Results Of A Long Term Longitudinal Growth Study And Pediatric Safety Information |
| M-25 |
Additional Safety & Pk Information In Children 6 Months To Less Than 6 Years Of Age Added To Pkg Insert |
| M-26 |
Incorporation Of Information Contained In The Peg-Intron Package Insert Into The Rebetol Package Insert And Medguide-Peg-Intron Was Approved For Use In Combination With Rebetol For Treatment Of Chronic Hepatitis C Virus Infection On 8/7/01 |
| M-27 |
Information Describing Aspirin Endoscopy Study And The Maximum Recommended Dose For Patients With Moderate Hepatic Insufficiency |
| M-28 |
Information From A Study In Pediatric Patients In Association With A Neurological Condition |
| M-29 |
Labeling Changes To Provide Information In The Management Of Obesity In Adolescents Aged 12 To 16 Years |
| M-3 |
Addition Of Efficacy And Safety Information In Which Fosamax Was Used Concomitantly With Estrogen Alone Or With Estrogen Plus Progestin |
| M-30 |
Changes To Clinical Pharmacology, Precautions, And Dosage And Administration Sections Of Labeling Concerning Use Of Lotensin In Pediatric Patients With Hypertension |
| M-31 |
Information For Use In Pediatric Patients With Chronic Kidney Disease Stage 5 (End-Stage Renal Disease) |
| M-32 |
Additional Language To Clinical Pharmacology And Clinical Studies |
| M-33 |
Information For Use Of Advair Diskus 100/50 In Children 4 To 11 Years Of Age With Asthma |
| M-34 |
Expanded Information To Pediatric Use Subsection Of Labeling In Response To Pediatric Written Request |
| M-35 |
Additional Information Regarding Clinical Studies Done With Actos In Combination With Metformin, A Sulfonylurea, Or Insulin Added To Clinical Pharmacology |
| M-36 |
Addition Of Information To Clinical Studies Regarding Prevention Of Cardiovascular Disease |
| M-37 |
Information Added To The Labeling That Details Information Relative To Studies Done In Pediatric Populations In The Clinical Pharmacology And Pediatric Use Subsections |
| M-38 |
Safety And Iop-Lowering Effects Of Trusopt Have Been Demonstrated In Pediatric Patients In A 3 Month, Multi-Center Double Masked Active-Treatment-Controlled Trial |
| M-39 |
For Labeling Changes Based On Results Of The Spd422-202 Clinical Study Report (Csr) Submitted In Response To The Written Request |
| M-4 |
Changes To Pediatric Use Section To Provide Information Regarding Safety And Efficacy In Pediatric Patients As Young As 2 Years Old |
| M-40 |
Additional Information Regarding Clinical Studies Performed In Pediatric Patients With Leukemia Added To Precautions |
| M-41 |
Revision To The Pediatric Use Precautions Of The Prescribing Information To Incorporate The Results From The Capps-169 Study Entitled "The Effect Of Ortho Tricyclen On Bone Mineral Denisty In Pediatric Subjects With Anorexia Nervosa" |
| M-42 |
Addition Of A Geriatric Use Subsection To The Precautions Section Of The Package Insert And Geriatric Dosing Information |
| M-43 |
Inclusion Of Results Of Study-"Placebo-Controlled Study To Evaluate Safety And Pilot Efficacy Of Iloprost As Add On Therapy With Bosentan In Subjects With Pulmonary Arterial Hypertension |
| M-44 |
Clinical Information Added To The Pediatric Use Subsection Of Precautions Regarding The Use Of Novolog In Adolescents With Type I Diabetes Age 6 To 18 |
| M-45 |
Information Added To Clinical Trials Section Of Labeling - Effects Of Humatrope Treatment In Adults With Growth Hormone Deficiency |
| M-46 |
Provision Of Results Of Study And Proposed Revisions To Package Insert See Section On Cardiac Electrophysiology |
| M-47 |
Provides For Use Of Antara Without Regard To Meals |
| M-48 |
Changes To The Labeling Describing The Results Of A Study Of The Use Of Novolog Mix 70/30 With Oral Antidiabetic Agents In Patients With Type 2 Diabetes |
| M-49 |
Clinical Data Added To The Clinical Pharmacology Section Regarding Effect Of Singulair On Growth Rates In Prepubertal Children |
| M-5 |
Information Regarding Effects In Patients With Asthma On Concomitant Inhaled Corticosteroids In Clinical Pharmacology Section |
| M-50 |
New Info To The Clinical Studies, Adult Growth Hormone Deficiency (Ghd) Subsection Of The Nutropin Aq Package Insert Describing The Effects Of Somatropin On Visceral Adipose Tissue In The Adult Growth Hormone Deficient Patient Population |
| M-51 |
Information Added To Labeling Regarding Osteogenesis Imperfecta Study |
| M-52 |
Information Added To The Clinical Pharmacology/Clinical Studies Section Regarding The Use Of Risedronate Administered Once A Week In The Prevention Of Osteoporosis In Postmenopausal Women |
| M-53 |
For Labeling Changes To The Quality Of Life (Qol) Statement In The Approved Package Insert |
| M-54 |
Information From Pediatric Studies Added To Label |
| M-55 |
Information On Results Of A Study Of The Use Of Sandostatin Lar Depot In Pediatric Patients With Hypothalamic Obesity. |
| M-56 |
Information Added To Clinical Trial Section With Information On "Gemini" Trial |
| M-57 |
Clinical Data Added To The Clinical Pharmacology Section Regarding The Pharmacokinetics Of Ezetimibe In Asian Subjects |
| M-58 |
Changes To The Clinical Studies, Primary Hypercholesterolemia, Vytorin Subsection Of The Package Insert To Add Efficacy Data For The Ezetimibe/Simvastatin Combination Product And For An Atorvastatin Product On Ldl-C And Other Lipid Prmtrs |
| M-59 |
Results Of The T20-310 Study Which Evaluated The Pharmacokinetics, Safety, And Antiviral Activity Of Fuzeon In Treatment Experienced Pediatric Subjects And Adolscents Was Added To The Pediatric Subsection Of Precautions |
| M-6 |
Additional Information Regarding Clinical Studies Done With Glucophage/Glyburide Combination Added To Clinical Pharmacology And Dosing And Administration |
| M-60 |
Changes To Clinical Studies, Primary Hypercholesterolemia, To Add Efficacy Data For The Ezetimibe/Simvastatin Combination Product And For A Rosuvastatin Product On Ldl-C And Other Lipid Parameters In Patients Wth Hypercholesterolemia |
| M-61 |
Revisions To Labeling Based On Data Submitted In Response To Pediatric Written Request |
| M-62 |
Clinical Information From One Clinical Study Investigating The Use Of Avandamet Plus Insulin In Patients With Type 2 Diabetes Mellitus Who Have Not Achieved Adequate Glycemic Control With Previous Anti-Diabetic Therapies |
| M-63 |
Detailed Information On An Inconclusive Pediatric Study |
| M-64 |
Changes To Clinical Pharmacology Detailing Study Results |
| M-65 |
Addition Of Information To Label To Include Information Regarding Use In Patients With Hiv-Associated Adipose Redistribution Syndrome (Hars) |
| M-66 |
Use In Specific Populations - Patients With Concomitant Illness Subsection Of The Labeling Regarding Use Of Strattera In Patients With Adhd Who Have Comorbid Tic Disorder |
| M-67 |
Indication Expanded To Include Patients On Peritoneal Dialysis |
| M-68 |
Description Of Results Of Study Of Initial Therapy In Combination With Metformin When Diet And Exercise Do Not Provide Glycemic Control |
| M-69 |
Results Of Study Of Combination Therapy And Non-Inferiority Study |
| M-7 |
Clinical Pharmacology In Pediatric Patients; Dosage And Administration Information |
| M-70 |
Provision Of Information Of The Results Of A Phase 2 Randomized Trial Of Sprycel 70mg Twice Daily Or Imatinib 800mg Daily |
| M-71 |
Revisions To Provide For Results Of Maintenance Data In Adult Patients With Major Depressive Disorder |
| M-72 |
Information About Use Of Inspra (Eplerenone) For Hypertension In Pediatric Patients |
| M-73 |
New Information Added Regarding The Tumor Shrinking Potential Of Sandostatin Lar Depot Injection On Gh - Secreting Pituitary Adenomas |
| M-74 |
Revisions To Clinical Studies - Children And Adolscents Based On Clinical Trial Data To Support A Duration Of Action Claim Up To 12 Hours |
| M-75 |
Provision For Use Of Argagatroban In Certain Pediatric Patients With Heparin-Induced Thrombocytopenia (Hit) Or Heparin-Induced Thrombocytopenia With Thrombosis (Hitts) |
| M-76 |
Removal Of Screen Requirement In Pts With G6pd Deficiency Prior To Initiating Aczone Treatment; Removal Of Blood Count & Reticulocyte Monitoring During Treatment In G6pd Deficient Pts And In Patients With History Of Anemia |
| M-77 |
Use In Combination With The New Aktilite Cl128 Lamp For The Treatment Of Thin And Moderately Thick, Non-Hyperkeratotic, Non-Pigmented Actinic Keratoses Of The Face And Scalp In Immunocompetent Patients |
| M-78 |
Clinical Trial Info On Use Of Strattera In Patients With Attention Deficit Hyperactivity Disorder (Adhd) And Comorbid Anxiety Disorder Without Causing Worsening Of Anxiety |
| M-79 |
Labeling Revisions Related To Smoking And Erlotimb Exposure |
| M-8 |
Additional Information For The Use Of Sonata Capsules For Up To 5 Weeks (35 Nights) Of Treatment In A Controlled Trial Setting |
| M-80 |
Additional Time Point Of 30 Minutes (0.5 Hour) In Children Aged 6-12 Years With A Diagnosis Of Attention-Deficit Hyperactivity Disorder (Adhd) |
| M-81 |
Additional Info For Pediatric Use For Casodex (Studied In Combination With Arimidex) In The Pediatric Population, Specifically Boys With Familial Male-Limited Precocious Puberty (Testoxicosis) |
| M-82 |
Labeling Revisions Related To Clinical Studies |
| M-83 |
Additional Information Added To Labeling Regarding Establishment Of Efficacy In Additional Clinical Trials And One Maintenance Trial |
| M-84 |
Study Information Added To Label Regarding Bone Mineral Density |
| M-85 |
Information Added To Labeling Regarding Use Of Prevacid In Patients Less Than 1 Year With Symptomatic Gerd |
| M-86 |
Labeling Changes Submitted In Response To Pediatric Written Request For Infants Ages Birth To 11 Month Inclusive Reflecting Lack Of Efficacy For Gerd Indication For This Patient Population |
| M-87 |
Inclusion Of Results From Two Drug Interaction Studies With Lipitor And Crestor In Clinical Pharmacology Section |
| M-88 |
Addition Of Information Regarding Abuse Potential Of Concerta Versus Immediate-Release Methylphenidate |
| M-89 |
Provides For Revisions To Multiple Sections Of The Package Insert To Reflect Results Of Clinical Trials 205.235 (Uplift) And 205.266 (Va Study) In Support Of Exacerbation Claim |
| M-9 |
Addition To The Clinical Studies Section Of The Labeling Of Text And Two Tables Containing Information For The Prescribing Physician On Blood Pressure, Heart Rate, And Heart Rate Variability |
| M-90 |
Labeling Changes Based On Data From Clinical Studies Nv20235 And Nv20236 Studies Of Seasonal Prophylaxis Of Influenza In Immunocompromised Patients And Children Ages 1-12 |
| M-91 |
Updated Labeling Based Upon Study: A Single-Dose, Single-Blind, Placebo-And Moxifloxacin-Controlled 2-Period, Randomized, Crossover, 3rd Period Sequential Study Of Side Effects Of Temsirolimus On Cardiac Repolarization In Healthy Subjects |
| M-92 |
Updates To The Package Insert Based Upon The Trial Entitled "A Phase I Pharmacokinetic And Pharmacodynamic Study Of Temsirolimus In Patients With Advanced Malignancies And Normal And Impaired Liver Function |
| M-93 |
Expansion Of Labeling To Include Information On Safety And Efficacy Of Creon In Patients Ages 7 Years Through 11 Years With Pancreatic Exocrine Insufficiency Due To Cystic Fibrosis |
| M-94 |
Info Added To Label Related To Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Ic Chronic Phase |
| M-95 |
Information For Treatment Of Chronic Hepatitis B (Chb) In Adult Patients With Decompensated Liver Disease Based On Data From Clinical Trial Gs-Us-174-0108 |
| M-96 |
Updated Information In The Clinical Studies Section Related To The Loss And Recovery Of Bone Mineral Density In Adolescent Girls During And Following The Use Of Depo-Provera Contraceptive Injection |
| M-97 |
Labeling Changes In Response To Pediatric Studies - Not Indicated For Use In Pediatric Population |
| M-98 |
New Information From A Study Which Evaluated The Safety And Efficacy Of Famvir In Treating Recurrent Genital Herpes In Immunocompetent Black/African American Subjects. |
| M-99 |
Addition Of Findings From A Single Pediatric Clinical Trial (P04292) Of Nasonex Nasal Spray In The Treatment Of Nasal Polyps In Patents 6 To <18 Years Of Age To The Package Insert. |
| NC |
New Combination |
| NCE |
New Chemical Entity |
| NDF |
New Dosage Form |
| NE |
New Ester Or Salt Of An Active Ingredient |
| NP |
New Product |
| NP* |
New Product (Mint Flavored) |
| NPP |
New Patient Population |
| NR |
New Route |
| NS |
New Strength |
| ODE |
Orphan Drug Exclusivity |
| PC |
Patent Challenge |
| PED |
Pediatric Exclusivity |
| RTO |
Rx To Otc Switch Or Otc Use |
| W |
Exclusivity On This Application Expiring On This Date Has Been Waived By Sponsor - See Section 1.8 Of Orange Book Preface Waived Exclusivity |
