Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Exclusivity Codes and Definitions

Codes Without Numbers

Code Definition
Code Definition
CGT COMPETITIVE GENERIC THERAPY
D NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)
GAIN GENERATING ANTIBIOTIC INCENTIVES NOW
I NEW INDICATION (SEE INDIVIDUAL REFERENCES)
M MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NC NEW COMBINATION
NCE NEW CHEMICAL ENTITY
NCE* NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
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
RTO* OTC USE FOR WOMEN AGES 15 AND 16
RTO** OTC USE FOR WOMEN AGE 14 AND BELOW
W EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY


Codes With Numbers

Code Definition
Code Definition
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 URTICARIA 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 TREATMENT 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 DARUNAVIR RESISTANCE ASSOCIATED SUBSTITUTIONS
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-135 UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
D-136 ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
D-137 NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS
D-138 80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
D-139 ADDITIONAL INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE LABELING REGARDING THE ADMINISTRATION OF BRAVELLE AND MENOPUR IN THE SAME SYRINGE TO OVULATORY WOMEN AS PART OF AN ART CYCLE
D-14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
D-140 REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY
D-141 DOSING INFORMATION IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA
D-142 DOSE MODIFICATION GUIDELINES FOR BORTEZOMIB WHEN GIVEN IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE
D-143 INITIATION OF VIMPAT THERAPY WITH A LOADING DOSE OF 200MG
D-144 LOWER LIMIT OF 15 MINUTES FOR THE INFUSION DURATION
D-145 UPDATES TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING TO REFLECT THE RESULTS OF TWO SHORT TERM STUDIES EVALUATING THE SAFETY AND EFFICACY OF INTUNIV IN CHILDREN AND ADOLESCENTS AGES 6 TO 17 WITH ADHD.
D-146 CHANGE IN TARGET DOSING TO 20MG TO 40MG ORALLY ONCE DAILY
D-147 ONCE DAILY DOSING IN PEDIATRIC PATIENTS 3 MONTHS OF AGE AND OLDER IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION
D-148 EXTENDED THE DURATION OF THE DOSING REGIMEN FROM 100 DAYS TO 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF CMV DISEASE IN PEDIATRIC KIDNEY TRANSPLANT
D-149 DOSING INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS 6 YEARS AND OLDER WITH ITP
D-15 SINGLE DAILY DOSE OF 25MG/37.5MG
D-150 1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE
D-151 DOSING RECOMMENDATIONS FOR THE TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS CO-INFECTED WITH HIV-1
D-152 DOSING RECOMMENDATIONS AS NECESSARY FOR FEVER AND PAIN FOR AGES 6MO TO LESS THAN 12 YEARS AND 12 TO 17 YEARS.
D-153 IN COMBINATION WITH RIBAVIRIN FOR 12 WEEKS, FOR THE TREATMENT OF GENOTYPE 1, CHRONIC HEPATITIS C TREATMENT EXPERIENCED PATIENTS WITH COMPENSATED CIRRHOSIS BASED UPON THE RESULTS OF THE SIRIUS STUDY
D-154 ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI)
D-155 SINGLE IV DOSE OF FOSAPREPITANT 150MG DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR ANTAGONIST & CORTICOSTEROID FOR PREVENTION OF DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
D-156 DOSING INFORMATION ADDED TO THE LABELING PROVIDING INFORMATION ON TRANSITIONING FROM SUBCUTANEOUS OR INTRAVENOUS ROUTES OF ADMINISTRATION OF TREPROSTINIL
D-157 UPDATED INFORMATION ADDED TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING PROVIDING DOSAGE RECOMMENDATIONS FOR INTERRUPTIONS AND DISCONTINUATION OF THERAPY
D-158 REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 1 HCV INFECTION
D-159 REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE LIVER TRANSPLANT RECIPIENTS WITH GENOTYPE 4 HCV INFECTION
D-16 CONTINUOUS INTRAVENOUS INFUSION
D-160 REVISED DOSING TO EXPAND PATIENT POPULATION TO INCLUDE PATIENTS WITH DECOMPENSATED CIRRHOSIS WITH GENOTYPE 1 HCV INFECTION
D-161 DOSAGE RECOMMENDATIONS ADDED TO INCLUDE TREATMENT OF HCV GENOTYPE 3 SUBJECTS CO-INFECTED WITH HIV-1
D-162 DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH COMPENSATED (CHILD-PUGH A) OR DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS AND TREATMENT OF CHRONIC HCV GENOTYPE 3 INFECTION IN SUBJECTS WITH DECOMPENSATED (CHILD-PUGH B OR C) CIRRHOSIS
D-163 DOSING TO INCLUDE PATIENTS WITH CHRONIC HCV GENOTYPE 1A INFECTION WITH COMPENSATED (CHILD-PUGH A) CIRRHOSIS AND GENOTYPE 1B WITH OR WITHOUT COMPENSATED (CHILD-PUGH A) CIRRHOSIS
D-164 UPDATES TO THE DOSAGE AND ADMINISTRATION, DOSE MODIFICATIONS SECTION OF THE LABELING
D-165 DOSING RECOMMENDATION ADDED TO THE LABELING FOR IMBRUVICA USE IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LEUKEMIA (SLL)
D-166 BROADEN INITIAL STARTING DOSE FOR BIPOLAR I DISORDER TO 5-10MG TWICE DAILY
D-167 ADDITION OF 1200 MG ONCE DAILY DOSING FOR TREATMENT-NAIVE PATIENTS OR PATIENTS WHO ARE VIROLOGICALLY SUPPRESSED ON AN INITIAL REGIMEN OF RALTEGRAVIR FILM-COATED TABLETS 400 MG TWICE DAILY
D-168 NEW DOSING REGIMEN OF 10 MG ONCE DAILY FOR THE REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR DVT AND/OR PE AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
D-169 ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE
D-17 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
D-170 TO ALLOW WITHDRAWAL THERAPY OF PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE WHO HAVE ACHIEVED A SUSTAINED MOLECULAR RESPONSE ON NILOTINIB THERAPY FOR A MINIMUM OF ONE YEAR PRIOR TO DISCONTINUATION
D-171 REVISED DOSING TO INCLUDE UP-TITRATION AS A STRATEGY TO IMPROVE TOLERABILITY AND THEREBY REDUCE TREATMENT DISCONTINUATION FOR ROFLUMILAST MAINTENANCE DOSAGE OF 500 MCG DAILY
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 PROPHYLAXIS 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 ADMINISTRATION OF CISATRACURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X THE ED95 OF CISATRACURIUM 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 DEFICIT 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 BEFORE 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-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 PATIENTS 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 CORONARY 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 LEUKOCYTE 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 INTRAVENOUS 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 PNEUMOCYSTIS 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 [ENCOMPASSES SPINAL AND CEREBRAL ORIGIN]
I-154 PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
I-155 TREATMENT OF ONYCHOMYCOSIS 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 ONYCHOMYCOSIS 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 SULFONYLUREA 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 TRANSFUSION 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 SODIUM 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 INFLAMMATION
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 MELLITUS 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-FLUOROURACIL AND LEUCOVORIN 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 RHEUMATOID 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 SYMPTOMS 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 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 THAN OR EQUAL TO 2 YEARS OF AGE
I-388 TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I-389 SUPPRESSION 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 RECURRENCE AFTER STEM CELL TRANSPLANT OR RESISTANCE TO INTERFERON ALPHA THERAPY. NO CONTROLLED TRIALS DEMONSTRATING A CLINICAL BENEFIT SUCH AS IMPROVEMENT 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 SUPPRESSIVE 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 IDENTIFICATION 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 ELOXATIN 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 CROHN'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 SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS
I-458 USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIIA 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 REDUCE THE RISK OF CARDIOVASCULAR MORTALITY OR NON-FATAL MYOCARDIAL INFARCTION
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 RECEIVING AN ERYTHROPOIETIN
I-475 PREVENTION OF NAUSEA AND VOMITING 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 INFLAMMATORY 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 IMMUNOCOMPETENT 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 IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
I-51 TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY MENSTRUAL BLOOD LOSS
I-510 ADULT DERMATOFIBROSARCOMA 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 RECURRENCE 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 PERITONITIS 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 EXACERBATIONS 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 HYPERACTIVITY 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 (FREDRICKSON 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 PROCEDURES
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 ARTERIAL 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 PATIENTS 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-656 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) IN ADULTS WHEN A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME
I-657 PLAQUE PSORIASIS OF THE SCALP
I-658 FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER, IN COMBINATION WITH CARBOPLATIN, IN PATIENTS WHO ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION THERAPY
I-659 PLAQUE PSORIASIS OF THE BODY
I-66 UNCOMPLICATED GONORRHEA
I-660 TREATMENT OF DEEP VEIN THROMBOSIS
I-661 TREATMENT OF PULMONARY EMBOLISM
I-662 REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY EMBOLISM
I-663 IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
I-664 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
I-665 TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS OF AGE AND OLDER WITH (NTDT)SYNDROMES AND WITH A (LIC) OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT (MG FE/G DW) AND SERUM FERRITIN GREATER THAN 300MCG/L
I-666 TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) IN COMBINATION WITH CHEMOTHERAPY
I-667 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH IMATINIB MESYLATE AND SUNITINIB MALATE
I-668 PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
I-669 SCINTIGRAPHIC ASSESSMENT OF SYMPATHETIC INNERVATION OF THE MYOCARDIUM BY MEASUREMENT OF THE HEART TO MEDIASTINUM (H/M) RATIO OF RADIOACTIVITY UPTAKE IN PATIENTS WITH NYHA CLASS II OR CLASS III HEART FAILURE AND LVEF LESS THAN 35%
I-67 TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
I-670 TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC, NON-CANCER PAIN
I-671 FIRSTLINE TREATMENT OF PATIENTS WITH METASTATIC NON- SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21(L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
I-672 USE IN PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
I-673 TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA/VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) CAUSED BY SUSCEPTIBLE ISOLATES OF S. AUREUS (INCLUDING METHICILLIN-SUSCEPTIBLE AND RESISTANT ISOLATES) WHEN ALTERNATIVE TREATMENTS ARE NOT SUITABLE
I-674 TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE
I-675 MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-676 FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS, IN COMBINATION WITH GEMCITABINE
I-677 TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA (DTC) THAT IS REFRACTORY TO RADIOACTIVE IODINE TREATMENT
I-678 TRAMETINIB, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
I-679 RISK REDUCTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
I-68 CENTRAL PRECOCIOUS PUBERTY
I-680 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
I-681 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) WHICH MAY LEAD TO PULMONARY EMBOLISM (PE), IN ADULT PATIENTS WHO HAVE UNDERGONE HIP OR KNEE REPLACEMENT
I-682 TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS
I-683 TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED
I-684 PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING HIGHLY EMETOGENIC CANCER CHEMOTHERAPY IN PEDIATRIC PATIENTS AGED 1 MONTH TO LESS THAN 17 YEARS
I-685 EXPANDED INDICATION OF RASAGILINE AS AN ADD-ON THERAPY TO STABLE DOSES OF DOPAMINE AGONISTS IN THE TREATMENT OF EARLY PARKINSON'S DISEASE
I-686 INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA IN PATIENTS WHO ARE PSEUDOPHAKIC OR ARE PHAKIC AND SCHEDULED FOR CATARACT SURGERY
I-687 GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
I-688 GADAVIST IS INDICATED WITH MRI TO DETECT THE PRESENCE AND EXTENT OF MALIGNANT BREAST DISEASE
I-689 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
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-690 INDICATED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
I-691 INDICATED TO REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) FOLLOWING INITIAL THERAPY
I-692 INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN.
I-693 TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC)
I-694 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
I-695 REVISED INDICATION FOR BORTEZOMIB IN THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA
I-696 USE AS MONOTHERAPY IN THE TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGE 17 YEARS AND OLDER
I-697 FOR USE IN COMBINATION WITH SOFOSBUVIR FOR THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1 INFECTION
I-698 SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
I-699 FOR TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
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-700 TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)
I-701 FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE, WELL-OR MODERATELY-DIFFERENTIATED, LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) TO IMPROVE PROGRESSION FREE SURVIVAL
I-702 FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA
I-703 MODERATE TO SEVERE BINGE EATING DISORDER (BED)
I-704 EXPANDED INDICATION TO INCLUDE PATIENTS WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA <50 COPIES/ML) ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TREATMENT FAILURE IN ORDER TO REPLACE THEIR CURRENT REGIMEN
I-705 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE
I-706 EXPANDED INDICATION FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
I-707 POMALYST, IN COMBINATION WITH DEXAMETHASONE, IS INDICATED FOR PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
I-708 DAILY TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER
I-709 TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS
I-71 VARICELLA INFECTIONS (CHICKENPOX)
I-710 ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC (PG TC) SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER.
I-711 INCLUSION OF PEDIATRIC PATIENTS AGES 6 YRS AND OLDER FOR THE TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC ITP WHO HAVE HAD AN INSUFFICIENT RESPONSE TO CORTICOSTEROIDS, IMMUNOGLOBULINS, OR SPLENECTOMY.
I-712 EXPANDED INDICATION FOR USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE PRIOR LINES OF THERAPY
I-713 REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ('INDUCTION') TREATMENT OF OPIOID DEPENDENCE
I-714 EXTENDS THE 2011 APPROVAL OF BRILINTA FOR USE BEGINNING WITH ACS TO USE BEGINNING MORE REMOTE FROM MYOCARDIAL INFARCTION
I-715 FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET SEIZURES IN ADULTS.
I-716 REVISED INDICATION TO INCLUDE LANGUAGE ABOUT THE BENEFITS OF USING LETAIRIS IN COMBINATION WITH TADALAFIL TO REDUCE THE RISK OF DISEASE PROGRESSION AND HOSPITALIZATION FOR WORSENING PAH AND TO IMPROVE EXERCISE ABILITY, BASED ON THE AMBITION STUDY
I-717 EXPANDED INDICATION TO INCLUDE THE TREATMENT OF CHRONIC HEPATITIS C GENOTYPE 4
I-718 EXPANDED INDICATION TO INCLUDE SUBJECTS INFECTED WITH CHRONIC HEPATITIS C, GENOTYPE 6 VIRUS INFECTION BASED UPON THE RESULTS OF THE ELECTRON- 2 STUDY
I-719 EXPANDED INDICATION TO INCLUDE THE TREATMENT OF SUBJECTS WITH GENOTYPE 5 CHRONIC HEPATITIS C VIRUS INFECTION BASED ON THE RESULTS FROM STUDY GS-US-337-119.
I-72 PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
I-720 EXPANDED INDICATION TO INCLUDE TREATMENT OF GENOTYPE 4, CHRONIC HEPATITIS C VIRUS INFECTION BASED UPON THE RESULTS FROM STUDIES ION-4 AND GS-US-337-119.
I-721 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.
I-722 REVISED INDICATION FOR USE IN COMBINATION WITH DEXAMETHASONE OR WITH LENALIDOMIDE PLUS DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY.
I-723 AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE OR MORE LINES OF THERAPY
I-724 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL DIFFERENTIATED, NON-FUNCTIONAL NEUROENDOCRINE TUMORS (NET) OF GI OR LUNG ORIGIN WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
I-725 TREATMENT OF HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER IN COMBINATION THERAPY WITH PALBOCICLIB AND FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY.
I-726 EXPANSION OF THE PATIENT POPULATION TO INCLUDE PATIENTS WITH RECURRENCE OF HEPATITIS C VIRUS (HCV) GENOTYPE 1 OR 3 AFTER LIVER TRANSPLANTATION
I-727 EXPANSION OF THE INDICATION TO INCLUDE TREATMENT OF SUBJECTS WITH GENOTYPE-1 CHRONIC HEPATITIS C VIRUS INFECTION, INCLUDING SUBJECTS WHO ARE CO-INFECTED WITH THE HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) BASED ON THE RESULTS FROM THE ALLY-2 CLINICAL TRIAL
I-728 EXPANDED INDICATION FOR USE IN ULTRASONOGRAPHY OF THE LIVER FOR CHARACTERIZATION OF FOCAL LIVER LESIONS IN ADULT AND PEDIATRIC PATIENTS
I-729 PROVIDES FOR THE FRONTLINE INDICATION FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
I-73 INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC PROCEDURES
I-730 NEW INDICATION FOR THE TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
I-731 FOR USE IN MAGNETIC RESONANCE ANGIOGRAPHY IN ADULT AND PEDIATRIC PATIENTS (INCLUDING TERM NEONATES) TO EVALUATE KNOWN OR SUSPECTED SUPRA-AORTIC OR RENAL ARTERY DISEASE
I-732 TREATMENT OF PEDIATRIC PATIENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA TO REDUCE LDL-C, TOTAL C, NONHDL-C AND APOB AS AN ADJUNCT TO DIET, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS
I-733 USE OF CANAGLIFLOZIN FOR INITIAL THERAPY IN COMBINATION WITH METFORMIN
I-734 EXPANDED INDICATION FOR THE USE OF LENVIMA IN COMBINATION WITH EVEROLIMUS FOR THE TREATMENT OF PATIENTS WITH ADVANCED RCC FOLLOWING ONE PRIOR ANTI-ANGIOGENIC THERAPY.
I-735 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH CANAGLIFLOZIN AND METFORMIN IS APPROPRIATE
I-736 REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL)
I-737 REVISED INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA (SLL) WITH 17P DELETION
I-738 REVISIONS TO THE INDICATIONS AND USAGE SECTION WITH RESPECT TO COMPLICATED INTRA-ABDOMINAL INFECTIONS
I-739 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
I-74 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-740 EXPANDED INDICATION FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER TO INCLUDE THE G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R MUTATION IN THE CFTR GENE
I-741 TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
I-742 TREATMENT OF NODAL MARGINAL ZONE LYMPHOMA
I-743 INFORMATION ADDED TO THE LABELING FOR THE ADDITION OF THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 4 (GT4) INFECTED PATIENTS WITH COMPENSATED CIRRHOSIS BASED ON RESULTS FROM STUDY M11-665
I-744 TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
I-745 MEKINIST, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.
I-746 NEW INDICATION OF MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER IN ADULTS
I-747 FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED WITH HIGH-DOSE BUSULFAN AND CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION FOR PEDIATRIC PATIENTS WITH CLASS 3 BETA-THALASSEMIA
I-748 TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS FIVE YEARS OF AGE AND OLDER
I-749 MONOTHERAPY FOR THE TREATMENT OF HORMONE RECEPTOR (HR) POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN NOT PREVIOUSLY TREATED WITH ENDOCRINE THERAPY
I-75 TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
I-750 REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
I-751 TREATMENT OF TARDIVE DYSKINESIA
I-752 CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA) TO ASSIST DIAGNOSTIC EVALUATION OF PATIENTS WITH SUSPECTED CORONARY ARTERY DISEASE
I-753 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
I-754 TO REDUCE THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY WHEN USED FOR THE TREATMENT OF ADULTS WITH CARCINOID SYNDROME
I-755 ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RENAL CELL CARCINOMA (RCC) FOLLOWING NEPHRECTOMY
I-756 EXPANDED THE APPROVED INDICATION BY REMOVING THE RESTRICTION FOR USE ONLY IN PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
I-757 TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
I-758 FOR USE WITH RILPIVIRINE AS A COMPLETE REGIMEN TO REPLACE THE CURRENT ARV REGIMEN IN VIROLOGICALLY SUPPRESSED PATIENTS ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS WITH NO HISTORY OF TX FAILURE OR KNOWN SUBSTITUTIONS ASSOC. WITH RESISTANCE TO EITHER ARV
I-759 TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+CML)
I-76 PREVENTION OF OSTEOPOROSIS
I-760 FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
I-761 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO METHOTREXATE OR OTHER NON-BIOLOGIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS
I-762 TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE METASTATIC BREAST CANCER WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT OR METASTATIC SETTING
I-763 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR RECEPTOR MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
I-764 TREATMENT IN ADULT PATIENTS FOR IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C)
I-765 ABIRATERONE ACETATE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC HIGH-RISK CASTRATION-SENSITIVE PROSTATE CANCER
I-766 TREATMENT OF MINIMALLY TO MODERATELY THICK ACTINIC KERATOSIS OF THE UPPER EXTREMITIES IN CONJUNCTION WITH A BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
I-767 TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON
I-768 IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
I-769 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
I-77 DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON FLOCCOSUM
I-770 TREATMENT OF ACUTE OTITIS EXTERNA IN PATIENTS 6 MONTHS OF AGE AND OLDER DUE TO PSEUDOMONAS AERUGINOSA AND STAPHYLOCOCCUS AUREUS
I-771 REVISION OF THE INDICATION SECTION OF THE PACKAGE INSERT REGARDING AN INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK TO PRODUCE POSTSURGICAL REGIONAL ANALGESIA
I-772 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
I-773 FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGE 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
I-774 TO ALLOW FOR FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS, AS DETECTED BY AN FDA APPROVED TEST
I-775 REVISED INDICATION FOR FIXED-DOSE COMBINATION OF FLUTICASONE FUROATE, UMECLIDINIUM, AND VILANTEROL TO TREAT AIRFLOW OBSTRUCTION IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND TO REDUCE COPD EXACERBATIONS IN PTS WITH HISTORY OF EXACERBATIONS
I-777 CO-ADMINISTRATION THERAPY OF MIRABEGRON WITH SOLIFENACIN SUCCINATE FOR TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
I-778 DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
I-779 USE OF TOLVAPTAN TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
I-78 CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND INTRAVENOUS EXCRETORY UROGRAPHY
I-780 TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC)
I-781 DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
I-782 REVISIONS TO INDICATION FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
I-783 EXPANDED INDICATION TO INCLUDE RIBOCICLIB WITH AN AROMATASE INHIBITOR IN PRE/PERIMENOPAUSAL WOMEN WITH HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY
I-784 RIBOCICLIB WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY
I-785 TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
I-786 TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
I-787 FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
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-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-118 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36
M-119 LABELING CHANGES REGARDING MISSED DOSES
M-12 NEW LANGUAGE FOR PEDIATRIC USE
M-120 CHANGES TO CLINICAL TRIALS DETAILING STUDY RESULTS
M-121 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.43
M-122 LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL
M-123 UPDATED RESULTS OF OVERALL SURVIVAL FROM 'CONFIRM' STUDY
M-124 LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015 STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS
M-125 LABELING CHANGES TO INCLUDE LACK OF EFFICACY IN CHILDREN 6 MONTHS TO 4 YEARS OF AGE
M-126 UPDATES TO THE CLINICAL STUDIES SECTION 14, OF THE PACKAGE INSERT (PI), WITH THE RESULTS OF CLINICAL TRIAL P06086
M-127 REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE RESULTS FROM CLINICAL STUDY C-10-004
M-128 CLINICAL TRIAL STUDY RESULTS
M-129 RESULTS OF A CLINICAL STUDY REPORT WHICH ASSESSES THE SAFETY AND EFFICACY IN CHILDREN AGES 6 TO 12 YEARS OF AGE
M-13 INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION
M-130 ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS SECTION OF THE PACKAGE INSERT
M-131 INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS
M-132 REVISIONS TO THE CLINICAL TRIALS SECTION IN THE INOMAX LABEL TO REFLECT RESULTS FROM THE PEDIATRIC STUDY REPORTS
M-133 INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN THERAPY
M-134 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN COMBINATION WITH METFORMIN AND A SULFONYLUREA ADDED TO THE LABELING
M-135 ADDITION OF INFORMATION TO THE CLINICAL STUDIES - RADIOGRAPHIC RESPONSE SECTION OF THE PACKAGE INSERT
M-136 ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC PATIENTS
M-137 LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
M-138 INFORMATION ADDED TO THE 8.4 PEDIATRIC USE SECTION ON THE USE OF MEMANTINE IN CHILDREN AGES 6-12 YEARS WITH AUTISM SPECTRUM DISORDER
M-139 INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE PACKAGE INSERT REGARDING RETREATMENT WITH VELCADE FOR PATIENTS WITH MULTIPLE MYELOMA
M-14 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
M-140 INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA, AND ADOLESCENTS WHO HAD HYPERTRICHOSIS WITH NO ASSOCIATED MEDICAL CONDITION
M-141 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING TO INCORPORATE STUDY RESULTS FOR TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADOLESCENTS (AGES 12-17)
M-142 ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY
M-143 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN PATIENTS WITH CURRENT OR PAST HISTORY OF MAJOR DEPRESSIVE DISORDER
M-144 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN PATIENTS WHO HAD BEEN PREVIOUSLY TREATED WITH VARENICLINE
M-145 ADDITION OF INFORMATION ABOUT LONG-TERM TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO THE CLINICAL STUDIES SECTION OF THE LABELING
M-146 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION ON INITIAL COMBINATION THERAPY WITH LINAGLIPTIN AND METFORMIN VS. LINAGLIPTIN MONOTHERAPY IN TREATMENT NAIVE PATIENTS
M-147 OTC USE FOR TEMPORARY RELIEF OF OCULAR SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES
M-148 LABELING CHANGES BASED ON STUDY H80-EW-GWDM
M-149 INFORMATION ADDED TO THE LABELING REGARDING MAINTENANCE MONOTHERAPY FOR ADHD
M-15 LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
M-150 ADDITION OF THE RESULTS OF A CONTROLLED CLINICAL STUDY TREATING ADULT PATIENTS WITH SCHIZOPHRENIA EXPERIENCING AN ACUTE RELAPSE
M-151 REVISIONS TO THE LABELING BASED ON THE OUTCOMES OF PEDIATRIC STUDIES CONDUCTED TO ASSESS THE SAFETY AND EFFICACY OF XOPENEX IN SUBJECTS LESS THAN 6 YEARS OF AGE
M-152 INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION OF THE LABELING REGARDING A SAFETY STUDY IN PEDIATRIC SUBJECTS AGES 6 MONTHS TO 4 YEARS OF AGE WITH AN ACTIVE HEAD LICE INFESTATION
M-153 ADDITION OF INFORMATION REGARDING THE INTRANASAL ABUSE POTENTIAL OF OXYCONTIN
M-154 UPDATE TO THE LABELING TO REFLECT THE RESULTS OF A LONG-TERM MAINTENANCE TREATMENT STUDY OF ADHD IN CHILDREN AND ADOLESCENTS AGES 6-17.
M-155 ADDITION OF CLINICAL FINDINGS FROM AN OBSERVATIONAL STUDY IN A PEDIATRIC AGE GROUP GREATER THAN 2 MONTHS TO 18 YEARS IN SECTION 8.4 PEDIATRIC USE OF THE PACKAGE INSERT
M-156 UPDATE TO THE LABELING WITH INFORMATION REGARDING A CLINICAL TRIAL IN CHILDREN LESS THAN 4 YEARS OF AGE.
M-157 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN 10MG ONCE DAILY IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND SULFONYLUREA
M-158 UPDATES TO THE LABELING TO REFLECT SAFETY RESULTS FROM CLINICAL TRIALS IN SCHIZOPHRENIA ADOLESCENT PATIENTS AGED 12 TO 17 YEARS
M-159 ADDITION OF PED SAFETY INFORMATION DERIVED FROM A MAINTENANCE TREATMENT STUDY OF BIPOLAR 1 DISORDER TO DELAY THE TIME TO OCCURRENCE OF MOOD EPISODES IN PATIENTS (> THAN OR = TO 13 YRS OF AGE) TREATED FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
M-16 CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
M-160 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND ACTIVE-CONTROLLED STUDY COMPARING EMPAGLIFLOZIN TO GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES AND INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN TREATMENT
M-161 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON A MULTIPLE DAILY INJECTION INSULIN REGIMEN ALONE OR WITH METFORMIN
M-162 INCLUSION OF EFFICACY AND SAFETY DATA TO THE PRESCRIBING INFORMATION OF BYDUREON BASED ON STUDY GWDE
M-163 INFORMATION ADDED TO THE LABELING REGARDING PREVIOUSLY UNTREATED ALK-POSITIVE METASTATIC NON SMALL CELL LUNG CANCER (NSCLC)
M-164 REVISES THE CLINICAL TRIALS SECTION OF THE PRESCRIBING INFORMATION TO INCORPORATE THE RESULTS FROM STUDY E7273-G000-401 ENTITLED 'PHASE IV RANDOMIZED STUDY OF TWO DOSE LEVELS OF TARGRETIN CAPSULES IN SUBJECTS WITH REFRACTORY CUTANEOUS T-CELL LYMPHOMA'
M-165 PROVIDES FOR UPDATES TO THE PEDIATRIC USE SECTION BASED ON THE PEDIATRIC STUDY REPORT ENTITLED, 'A PHASE II PILOT TRIAL OF BORTEZOMIB IN COMBINATION WITH INTENSIVE RE-INDUCTION THERAPY IN CHILDREN WITH RELAPSED ACUTE LYMPHOBLASTIC LYMPHOMA (LL)'
M-166 UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS
M-167 APPROVED FOR REVISIONS TO THE LABELING BASED ON THE CLINICAL STUDY ENTITLED 'BRONCHOPULMONARY DYSPLASIA (BPD) IN PRETERM INFANTS REQUIRING MECHANICAL VENTILATION OR POSITIVE PRESSURE SUPPORT ON DAYS 5 TO 14 AFTER BIRTH'.
M-168 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE RE-NOVATE AND RE-NOVATE LL STUDIES (PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM FOLLOWING HIP REPLACEMENT SURGERY)
M-169 UPDATES TO LABELING DESCRIBING RESPONSE TO A REPEAT COURSE OF PICATO GEL 0.015% ON THE FACE OR SCALP IF AN INCOMPLETE RESPONSE IS OBSERVED AT A FOLLOW-UP EXAMINATION.
M-17 INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART DISEASE
M-170 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION REGARDING USE FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
M-171 UPDATES TO LABELING WITH RESULTS TO THE TIGER CLINICAL TRIAL
M-172 UPDATES TO THE CLINICAL TRIALS SECTION OF THE LABELING TO INCLUDE RESULTS OF STUDIES PERFORMED TO EVALUATE THE BENEFIT OF ADDING INCRUSE ELLIPTA TO PATIENTS WHO ARE ON BACKGROUND THERAPY WITH BREO ELLIPTA AND ADVAIR DISKUS
M-173 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING DESCRIBING THE EFFECTS OF STIOLTO RESPIMAT ON COPD PATIENTS
M-174 INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
M-175 INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES
M-176 INFORMATION ADDED TO THE LABELING DESCRIBING TRIAL NN2211-3916, A TRIAL EVALUATING THE SAFETY AND EFFICACY OF LIRAGLUTIDE IN SUBJECTS WITH TYPE 2 DIABETES AND MODERATE RENAL IMPAIRMENT
M-177 INFORMATION ADDED TO THE LABELING DESCRIBING EXAMINE, A TRIAL EVALUATING CARDIOVASCULAR ISCHEMIC RISKS ASSOCIATED WITH ALOGLIPTIN USE IN PATIENTS WITH TYPE 2 DIABETES AT HIGH RISK OF ISCHEMIC CARDIOVASCULAR DISEASE
M-178 INFORMATION ADDED TO THE LABELING REGARDING MAINTENANCE OF REMISSION IN CROHN'S DISEASE IN PEDIATRIC PATIENTS
M-179 UPDATES TO THE PRODUCT LABELING WITH STUDY REPORTS FROM THE OPTIMIST-1 AND OPTIMIST-2 CLINICAL TRIALS
M-18 INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER (MDD)
M-180 INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF MAINTENANCE TREATMENT IN PATIENTS WITH SCHIZOPHRENIA
M-181 UPDATE TO THE DOSAGE AND ADMINISTRATION, PATIENT SELECTION (2.1), SECTION OF THE PACKAGE INSERT TO INCLUDE THE USE OF AN FDA-APPROVED PLASMA TEST FOR THE IDENTIFICATION OF EGFR EXON 19 DELETION OR EXON 21 (L858R) SUBSTITUTION MUTATIONS
M-182 UPDATES TO THE PRODUCT LABELING BASED ON THE RESULTS OF STUDY H7T-MC-TADO TITLED, 'A PHASE 3 DOUBLE-BLIND, RANDOMIZED, MULTICENTER, EFFICACY AND SAFETY STUDY OF PRASUGREL COMPARED TO PLACEBO IN PEDIATRIC PATIENTS WITH SICKLE CELL DISEASE'
M-183 CHANGES TO THE DOSAGE AND ADMINISTRATION AND CLINICAL STUDIES SECTIONS OF THE LABELING TO SUPPORT THE REDUCE-TO-QUIT PARADIGM
M-184 UPDATES MADE TO THE LABELING TO INCLUDE INFORMATION FROM STUDY MO25743 ON THE ANTI-TUMOR ACTIVITY OF VEMURAFENIB IN THE TREATMENT OF PATIENTS WITH BRAF V600E MUTATION-POSITIVE MELANOMA WITH BRAIN METASTASES
M-185 UPDATES TO THE LABELING TO INCLUDE RESULTS OF A TRIAL TO EVALUATE THE SAFETY OF MOXIFLOXACIN IN PEDIATRIC PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTIONS
M-186 UPDATES TO THE PRODUCT INFORMATION REGARDING MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS BASED UPON THE RESULTS FROM STUDY 331-10-232
M-187 ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
M-188 PROVIDES FOR DATA SUPPORTING THE SAFETY AND EFFECTIVENESS FOR THE MAINTENANCE TREATMENT OF MODERATE TO SEVERE BINGE EATING DISORDER (BED)
M-189 LABELING DESCRIBING THE EXPECTED REDUCTION OF ABUSE OF SINGLE-ENTITY MORPHINE BY THE INTRANASAL ROUTE OF ADMINISTRATION DUE TO PHYSICOCHEMICAL PROPERTIES
M-19 INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
M-190 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE LACK OF EFFICACY OF TARCEVA IN MAINTENANCE TREATMENT OF PATIENTS WITHOUT EGFR MUTATIONS
M-191 ADDITION OF DATA BASED ON PEDIATRIC STUDIES TO FULFILL THE POSTMARKETING REQUIREMENT 1857-2
M-192 PROVIDES FOR DATA EVALUATING THE NEUROPSYCHIATRIC SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN SUBJECTS WITH AND WITHOUT A HISTORY OF PSYCHIATRIC DISORDERS
M-193 INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
M-194 INFORMATION ADDED TO THE LABELING REGARDING USE OF REGADENOSON ADMINISTRATION FOLLOWING AN INADEQUATE EXERCISE STRESS TEST AS COMPARED TO REGADENOSON ALONE
M-195 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
M-196 REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM A RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER STUDY OF INTRAVENOUS ACETAMINOPHEN FOR THE TREATMENT OF ACUTE PAIN IN PEDIATRIC PATIENTS TO FULFILL THE POST-MARKETING REQUIREMENT 1704-1
M-197 NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
M-198 PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
M-199 INFORMATION ADDED TO LABELING REGARDING THE TREATMENT OF PATIENTS WITH ALK-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAD NOT RECEIVED PRIOR SYSTEMIC THERAPY FOR METASTATIC DISEASE.
M-2 APPROVAL FOR ADDITION 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-200 CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING.
M-201 REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM AN OPEN LABEL, MULTI-CENTER STUDY OF CABAZITAXEL IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS INCLUDING TUMORS OF THE CENTRAL NERVOUS SYSTEM.
M-202 INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT.
M-203 PROVIDES FOR REVISIONS TO THE PACKAGE INSERT TO REFLECT RESULTS OF TWO POSTMARKETING REQUIREMENT STUDIES ROP111662 AND ROP111569
M-204 CLINICAL INFORMATION ADDED TO THE PACKAGE INSERT REGARDING USE OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS AGES 10-17 WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)
M-205 INFORMATION ADDED TO THE LABELING REGARDING RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES ON PATIENTS WITH SEVERE RENAL IMPAIRMENT
M-206 INFORMATION ADDED TO LABELING REGARDING 48 WEEK EFFICACY, RESISTANCE AND SAFETY DATA ON VIROLOGICALLY SUPPRESSED HIV-1 INFECTED ADULTS SWITCHING FROM COMPLERA TO ODEFSEY
M-207 INFORMATION ADDED TO LABELING REGARDING 48 WEEK EFFICACY, RESISTANCE AND SAFETY DATA ON VIROLOGICALLY SUPPRESSED HIV-1 INFECTED ADULTS SWITCHING FROM ATRIPLA TO ODEFSEY
M-208 INFORMATION ADDED TO THE LABELING TO INCLUDE RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN PATIENTS WITH SEVERE COPD ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
M-209 INFORMATION ADDED TO THE LABELING REGARDING CABAZITAXEL AT 20 MG/M2 BASED ON THE RESULTS OF THE PROSELICA STUDY
M-21 COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
M-210 INFORMATION ADDED TO LABELING TO SUPPORT THE USE OF SYMBICORT TO REDUCE EXACERBATIONS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
M-211 PROVIDES FOR LABELING CHANGES REGARDING THE USE OF DAPTOMYCIN IN THE PEDIATRIC POPULATION FOR STAPHYLOCOCCUS AUREUS BACTEREMIA (SAB) BASED ON RESULTS OF A TRIAL IN PEDIATRIC PATIENTS 1 TO 17 YEARS OF AGE
M-212 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A BACKGROUND COMBINATION OF METFORMIN AND EXENATIDE EXTENDED RELEASE
M-213 INFORMATION ADDED TO THE LABELING TO INCLUDE THE EFFICACY AND SAFETY OF CARIPRAZINE RELATIVE TO PLACEBO IN THE PREVENTION OF RELAPSE OF SYMPTOMS IN PATIENTS WITH SCHIZOPHRENIA
M-214 INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS
M-215 INFORMATION ADDED TO THE LABELING REGARDING THE COMPARISON OF PALIPERIDONE PALMITATE COMPARED WITH ORAL ANTIPSYCHOTIC TREATMENT IN DELAYING TIME TO TREATMENT FAILURE IN ADULTS WITH SCHIZOPHRENIA WHO HAVE BEEN INCARCERATED
M-216 UPDATE THE PRESCRIBING INFORMATION AND PATIENT LABELING WITH FINDINGS FROM STUDY RP103-08 CONDUCTED IN TREATMENT-NAIVE NEPHROPATHIC CYSTINOSIS PATIENTS TO EXPAND THE INDICATED POPULATION TO PATIENTS 1 YEAR AND OLDER
M-217 INCORPORATION OF THE LABELING REVISIONS PROVIDED FOR IN NDA 022253/S-039 AND NDA 022255/S-022 INTO THE LACOSAMIDE INJECTION LABELING
M-218 ADDITIONAL INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS AGED 6 THROUGH 11 YEARS (TRIAL 4)
M-219 INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY
M-22 CHANGE IN TIME TO ONSET OF ACTION
M-220 ADDITIONAL INFORMATION ADDED TO THE LABELING FROM STUDY PC B308/13 REGARDING THE USE OF BLUE LIGHT CYSTOSCOPY WITH CYSVIEW AS AN ADJUNCT TO WHITE LIGHT CYSTOSCOPY
M-221 DRUG FACTS LABELING CHANGES UNDER THE DIRECTIONS HEADING TO REVISE THE STATED PREPARATION TIME OF A DRY SITE FROM 120 SECONDS SCRUBBING AND 90 SECONDS DRYING TO 30 SECONDS SCRUBBING AND 30 SECONDS DRYING
M-222 ADDITION OF DATA BASED ON THE ASSESSMENT OF SAFETY AND EFFICACY IN PEDIATRIC PATIENTS WITH MAJOR DEPRESSIVE DISORDER TO FULFILL POSTMARKETING STUDY REQUIREMENT 1229-1
M-223 INFORMATION ADDED TO SECTION 8.1 OF THE LABELING REGARDING PREGNANT PATIENTS WHO ARE ALREADY ON A STABLE RILPIVIRINE REGIMEN PRIOR TO PREGNANCY AND WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML)
M-224 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF EXENATIDE EXTENDED RELEASE AS ADD-ON IN PATIENTS WITH TYPE 2 DIABETES WHO HAVE INADEQUATE GLYCEMIC CONTROL ON BASAL INSULIN GLARGINE WITH OR WITHOUT METFORMIN
M-225 REVISIONS TO SECTION 8.4 OF THE PRESCRIBING INFORMATION TO INCLUDE A SAFETY AND EFFICACY STUDY IN PEDIATRIC PATIENTS AGES >=6 YEARS TO <18 YEARS WITH CHRONIC IDIOPATHIC CONSTIPATION
M-226 CHANGES TO THE LABELING BASED ON RESULTS FROM A CONTROLLED CLINICAL TRIAL IN PATIENTS WITH LATER-ONSET SPINAL MUSCULAR ATROPHY
M-227 ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING WITH THE SUBSECTION ENTITLED DIGIT SYMBOL SUBSTITUTION TEST IN MAJOR DEPRESSIVE DISORDER
M-228 INFORMATION ADDED TO THE PACKAGE INSERT REGARDING THE REVISION OF THE MONOTHERAPY INDICATION OF VENETOCLAX
M-229 REVISED LABELING TO INCORPORATE THE PEDIATRIC USE OF LOTEPREDNOL ETABONATE GEL IN PATIENTS FOR THE TREATMENT OF POSTOPERATIVE INFLAMMATION FOLLOWING OCULAR SURGERY
M-23 INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
M-230 REVISIONS TO THE GLECAPREVIR/PIBRENTASVIR COMBINATION PRODUCT PRESCRIBING INFORMATION TO INCLUDE SAFETY AND EFFICACY DATA FROM THE HCV/HIV-1 COINFECTION STUDY M14-730 AND FROM THE LIVER AND RENAL TRANSPLANT STUDY M13-596
M-231 REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION (SECTION 8.3) OF THE PACKAGE INSERT WITH THE RESULTS OF CLINICAL TRIAL WV25651, CONDUCTED TO EVALUATE THE EFFECT OF VALGANCYCLOVIR ON SPERMATOGENESIS AND TO FULFILL PMR 1670-3
M-24 INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY INFORMATION
M-25 ADDITIONAL SAFETY AND PHARMACOKINETICS INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE ADDED TO PACKAGE 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 DENSITY 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 ADOLESCENTS 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 ADOLESCENTS BASED ON CLINICAL TRIAL DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
M-75 PROVISION FOR USE OF ARGATROBAN 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 ERLOTINIB 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 (TESTOTOXICOSIS)
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 PATIENTS 6 TO <18 YEARS OF AGE TO THE PACKAGE INSERT.
ODE-1 TO REDUCE CHRONIC DROOLING IN PATIENTS AGED 3 - 16 WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING (E.G. CEREBRAL PALSY)
ODE-10 FOR USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER
ODE-100 FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA OR LEIOMYOSARCOMA WHO RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN
ODE-101 FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATION, IN COMBINATION WITH VEMURAFENIB. COTELLIC IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH WILD-TYPE BRAF MELANOMA
ODE-102 FOR TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), AS DETECTED BY AN FDA-APPROVED TEST, WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
ODE-103 USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-104 EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.
ODE-105 TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
ODE-106 FOR USE OF UPTRAVI (SELEXIPAG) TABLETS, 200, 400, 600, 800, 1000, 1200, 1400, AND 1600 MCG FOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I) TO REDUCE THE RISKS OF DISEASE PROGRESSION AND HOSPITALIZATION FOR PAH
ODE-107 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLNE-CONTAINING REGIMEN
ODE-108 TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL-DIFFERENTIATED, NON-FUNCTIONAL, NEUROENDOCRINE TUMORS (NET) OF GASTROINTESTINAL (GI) OR LUNG ORIGIN, (EXCLUDING PANCREATIC) WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
ODE-109 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
ODE-11 TREATMENT OF PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) IN PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
ODE-110 FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
ODE-111 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE.
ODE-112 FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT).
ODE-113 FOR TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH ACQUIRED METHEMOGLOBINEMIA.
ODE-114 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-115 TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
ODE-116 TREATMENT OF PROGRESSIVE KERATOCONUS
ODE-117 FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
ODE-118 AN ADJUNCT TO DIET TO REDUCE LDL-C, TOTAL-C, NONHDL-C AND APOB IN CHILDREN AND ADOLESCENTS 7 TO 17 YEARS OF AGE WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA, EITHER ALONE OR WITH OTHER LIPID-LOWERING TREATMENTS (E.G., LDL APHERESIS)
ODE-119 TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WITH AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN ADULTS UNABLE TO TOLERATE UDCA
ODE-12 TREATMENT OF PERIPHERAL T-CELL LYMPHOMA (PTCL) IN PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-120 FOR USE AFTER RADIOLABELING WITH GA 68, WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS.
ODE-121 TREATMENT OF CORNEAL ECTASIA FOLLOWING REFRACTIVE SURGERY
ODE-122 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
ODE-123 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6-11 YEAR OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
ODE-124 REPLACEMENT THERAPY FOR ORAL CARBAMAZEPINE FORMULATIONS, WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE, IN ADULTS WITH THE FOLLOWING SEIZURE TYPES: PARTIAL WITH COMPLEX SYMPTOMOLOGY, GENERALIZED CLONIC-TONIC, AND MIXED
ODE-125 INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
ODE-126 AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
ODE-127 TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS
ODE-128 TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
ODE-129 INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA
ODE-13 TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA WITH THE BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
ODE-130 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
ODE-131 TREATMENT OF MULTIPLE MYELOMA (MM), AS MAINTENANCE FOLLOWING AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION (AUTO-HSCT)
ODE-132 TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
ODE-133 INDICATED FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
ODE-134 TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
ODE-135 TREATMENT OF CHRONIC HCV GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
ODE-136 TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
ODE-137 TREATMENT OF OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PERSISTENT OLIGOARTHRITIS, PSORIATIC JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR UNDIFFERENTIATED ARTHRITIS) & POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS IN CHILDREN 0-16 YRS
ODE-138 TREATMENT OF PEDIATRIC PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS A COMPONENT OF A COMBINATION CHEOMOTHERAPY MAINTENANCE REGIMEN
ODE-139 TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC OR LIVER CANCER) WHO HAVE BEEN PREVIOUSLY TREATED WITH THE DRUG SORAFENIB.
ODE-14 TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA IN ADULTS 18 YEARS OF AGE AND OLDER
ODE-140 TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
ODE-141 TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 MUTATION-POSITIVE AS DETECTED BY AN FDA APPROVED TEST, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION
ODE-142 TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
ODE-143 TO DECREASE THE RECURRENCE OF PNEUMOTHORAX IN ADULTS
ODE-144 TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS)
ODE-145 TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST
ODE-146 OPTICAL IMAGING AGENT INDICATED IN PATIENTS WITH GLIOMA (SUSPECTED WORLD HEALTH ORGANIZATION GRADES III OR IV ON PREOPERATIVE IMAGING) AS AN ADJUNCT FOR THE VISUALIZATION OF MALIGNANT TISSUE DURING SURGERY
ODE-147 DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
ODE-148 TRAMETINIB IN COMBINATION WITH DABRAFENIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
ODE-149 TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY
ODE-15 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA APPROVED TEST
ODE-150 TO REDUCE THE ACUTE COMPLICATIONS OF SICKLE CELL DISEASE IN ADULT AND PEDIATRIC PATIENTS 5 YEARS OF AGE AND OLDER.
ODE-151 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH AN ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
ODE-152 TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
ODE-153 TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
ODE-154 FOR USE IN CHILDREN AGES 2 TO 12 YEARS OLD WITH CHAGAS DISEASE
ODE-155 TREATMENT OF ADULT PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
ODE-156 TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
ODE-157 FOR USE AS A NITROGEN-BINDING AGENT FOR CHRONIC MANAGEMENT OF PEDIATRIC PATIENTS >=2 MONTHS AND < 2 YEARS OF AGE WITH UREA CYCLE DISORDERS (UCDS) WHO CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE
ODE-158 TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
ODE-159 FOR TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE, METASTATIC NON-SMALL-CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST, EXCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
ODE-16 TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO THALASSEMIA SYNDROMES WHEN CURRENT CHELATION THERAPY IS INADEQUATE
ODE-160 FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED
ODE-161 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) IN PEDIATRIC PATIENTS AGED 3 YRS AND OLDER WITH IDIOPATHIC OR CONGENITAL PAH TO IMPROVE PULMONARY VASCULAR RESISTANCE (PVR), WHICH IS EXPECTED TO RESULT IN AN IMPROVEMENT IN EXERCISE ABILITY
ODE-162 TREATMENT OF NEPHROPATHIC CYSTINOSIS IN PEDIATRIC PATIENTS 1 YEAR OF AGE TO LESS THAN 2 YEARS OF AGE
ODE-163 TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
ODE-164 TREATMENT OF PEDIATRIC PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOID LEUKEMIA (CML) IN CHRONIC PHASE
ODE-165 PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV-SEROPOSITIVE RECIPIENTS [R+] OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT)
ODE-166 TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
ODE-167 ARSENIC TRIOXIDE FOR USE IN COMBINATION WITH TRETINOIN FOR TREATMENT OF ADULTS WITH NEWLY-DIAGNOSED LOW-RISK ACUTE PROMYELOCYTIC LEUKEMIA (APL) WHOSE APL IS CHARACTERIZED BY THE PRESENCE OF THE T(15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE EXPRESSION
ODE-168 FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
ODE-169 FOR THE ADJUNCTIVE TREATMENT OF ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH TUBEROUS SCLEROSIS COMPLEX (TSC)-ASSOCIATED PARTIAL-ONSET SEIZURES
ODE-17 ADJUNCTIVE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE OR OLDER
ODE-170 FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD)
ODE-171 TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML) IN CHRONIC PHASE
ODE-172 TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA WITH RESISTANCE OR INTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR THERAPY
ODE-173 TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AGED 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR
ODE-174 FOR THE TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
ODE-175 TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-176 INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
ODE-177 TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS
ODE-178 INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
ODE-179 TREATMENT OF PATIENTS WITH CLL AND TREATMENT OF PATIENTS WITH INDOLENT B-CELL NHL THAT HAS PROGRESSED DURING OR WITHIN SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
ODE-18 ADJUNCTIVE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME INPATIENTS 2 YEARS OF AGE OR OLDER
ODE-180 MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
ODE-181 TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
ODE-182 TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
ODE-183 TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
ODE-184 INDICATED IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF PEDIATRIC PATIENTS WITH HIV-1 INFECTION
ODE-185 INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-186 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, OR S549R
ODE-187 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AN R117H MUTATION IN THE CFTR GENE
ODE-188 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGES 2 TO LESS THAN 6 YEARS WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, AND R117H
ODE-189 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 YEARS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: 711+3A-G, E831X, 2789+5G-A, 3272-26A-G, AND 3849+10KBC-T
ODE-19 TREATMENT OF PATIENTS WITH INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS, INCLUDING PRIMARY MYELOFIBROSIS, POST-POLYCYTHEMIA VERA MYELOFIBROSIS AND POST-ESSENTIAL THROMBOCYTHEMIA MYELOFIBROSIS
ODE-190 TX OF CF IN PTS 2 YRS AND OLDER WHO HAVE ONE OF THE FOLLOWING MUTATIONS IN THE CFTR GENE: E56K, P67L, R74W, D110E, D110H, R117C, E193K, L206W, R347H, R352Q, A455E, D579G, S945L, S977F, F1052V, K1060T, A1067T, G1069R, R1070Q, R1070W, F1074L, D1152H, D1270N
ODE-191 TO DECREASE THE RECURRENCE OF MALIGNANT PLEURAL EFFUSIONS IN SYMPTOMATIC PATIENTS FOLLOWING MAXIMAL DRAINAGE OF THE PLEURAL EFFUSION
ODE-192 INDICATED TO INDUCE CONTROLLED CARDIAC SEPTAL INFRACTION TO IMPROVE EXERCISE CAPACITY IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC OBSTRUCTIVE CARDIOMYOPATHY WHO ARE NOT CANDIDATES FOR SURGICAL MYECTOMY
ODE-193 INDICATED FOR THE TREATMENT OF ONCHOCERCIASIS DUE TO ONCHOCERCA VOLVULUS IN PATIENTS AGED 12 YEARS AND OLDER
ODE-194 ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
ODE-195 FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 2 THROUGH 5 YEARS OLD WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE
ODE-196 INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
ODE-197 INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
ODE-198 INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM
ODE-199 THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 12 MONTHS AND OLDER WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA
ODE-2 FOR TREATMENT OF NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
ODE-20 TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A G551D MUTATION IN THE CFTR GENE.
ODE-200 INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG
ODE-201 INDICATED FOR THE RADICAL CURE (PREVENTION OF RELAPSE) OF PLASMODIUM VIVAX MALARIA IN PATIENTS AGED 16 YEARS AND OLDER WHO ARE RECEIVING APPROPRIATE ANTIMALARIAL THERAPY FOR ACUTE P. VIVAX INFECTION
ODE-202 INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC)
ODE-203 INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
ODE-204 TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH IOBENGUANE SCAN POSITIVE, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC PHEOCHROMOCYTOMA OR PARAGANGLIOMA WHO REQUIRE SYSTEMIC ANTICANCER THERAPY
ODE-205 INDICATED FOR THE TREATMENT OF ADULTS WITH A CONFIRMED DIAGNOSIS OF FABRY DISEASE AND AN AMENABLE GALACTOSIDASE ALPHA GENE (GLA) VARIANT BASED ON IN VITRO ASSAY DATA
ODE-21 AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY
ODE-22 FOR THE CONTROL OF HYPERGLYCEMIA SECONDARY TO HYPERCORTISOLISM IN ADULT PATIENTS WITH ENDOGENOUS CUSHING'S SYNDROME WHO HAVE TYPE 2 DIABETES MELLITUS OR GLUCOSE INTOLERANCE AND HAVE FAILED SURGERY OR ARE NOT CANDIDATES FOR SURGERY
ODE-23 ADVANCED SOFT TISSUE SARCOMA (STS) WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
ODE-24 TREATMENT OF ADULTS WITH RENAL ANGIOMYOLIPOMA AND TUBEROUS SCLEROSIS COMPLEX (TSC) NOT REQUIRING IMMEDIATE SURGERY
ODE-25 MANAGEMENT OF POSTHERPETIC NEURALGIA IN ADULTS.
ODE-26 TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
ODE-27 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
ODE-28 TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE (PH-) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS PROGRESSED FOLLOWING TWO OR MORE ANTI-LEUKEMIA THERAPIES
ODE-29 LOCALIZATION OF LYMPH NODES DRAINING A PRIMARY TUMOR IN PATIENTS WITH MELANOMA WHEN USED WITH A HAND-HELD GAMMA COUNTER
ODE-3 TO TREAT INFANTILE SPASMS
ODE-30 TREATMENT OF ADULT PATIENTS WITH CHRONIC, ACCELERATED OR BLAST PHASE PHILADELPHIA CHROMOSOME-POSITIVE (PH+) CHRONIC MYELOGENOUS LEUKEMIA (CML) WITH RESISTANCE, OR INTOLERANCE TO PRIOR THERAPY
ODE-31 TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS
ODE-32 TREATMENT OF ADULT PATIENTS WITH CHRONIC OR ACCELERATED PHASE CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE AND/OR INTOLERANCE TO TWO OR MORE TYROSINE KINASE INHIBITORS (TKI)
ODE-33 TREATMENT OF PROGRESSIVE, METASTATIC MEDULLARY THYROID CANCER (MTC)
ODE-34 TREATMENT OF ADULT PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
ODE-35 TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) THAT IS RESISTANT OR INTOLERANT TO PRIOR TYROSINE KINASE INHIBITOR THERAPY.
ODE-36 ADJUNCT TO A LOW-FAT DIET AND OTHER LIPID-LOWERING TREATMENTS, INCLUDING LDL APHERESIS WHERE AVAILABLE, TO REDUCE LDL-C, TC, APOLIPOPROTEIN B, & NON-HDL-C IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
ODE-37 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
ODE-38 PART OF COMBINATION THERAPY IN ADULTS (GREATER THAN OR EQUAL TO 18 YEARS) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)
ODE-39 TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS. & OLDER WITH NON-TRANSFUSION DEPENDENT THALASSEMIA (NTDT) SYNDROMES AND WITH A LIVER IRON CONCENTRATION OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY WEIGHT & SERUM FERRITIN GREATER THAN 300 MCG/L.
ODE-4 TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED WITH TUBEROUS SCLEROSIS WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT CANDIDATES FOR CURATIVE SURGICAL RESECTION
ODE-40 TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY, APPROVED UNDER NDA #21588/S-037
ODE-41 ADJUNCT TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LDL-C, APOLIPOPROTEIN B (APO B), TOTAL CHOLESTEROL (TC), AND NON-HIGH DENSITY LIPOPROTEIN-CHOLESTEROL (NON-HDL-C) IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
ODE-42 USE AS A NITROGEN-BINDING ADJUNCTIVE THERAPY FOR CHRONIC MGMT OF ADULT AND PEDIATRIC PATIENTS AT LEAST 2 YRS WITH UREA CYCLE DISORDERS THAT CANNOT BE MANAGED BY DIETARY PROTEIN RESTRICTION AND/OR AMINO ACID SUPPLEMENTATION ALONE
ODE-43 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR THERAPIES INCLUDING LENALIDOMIDE AND BORTEZOMIB AND HAVE DEMONSTRATED DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY.
ODE-44 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH IMATINIB MESYLATE AND SUNITINIB MALATE.
ODE-45 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS IN ADULTS AND CHILDREN AGES 6 YEARS AND OLDER.
ODE-46 IMPROVEMENT OF NEUROLOGICAL OUTCOME BY REDUCING THE INCIDENCE AND SEVERITY OF ISCHEMIC DEFICITS IN ADULT PATIENTS WITH SUBARACHNOID HEMORRHAGE FROM RUPTURED INTRACRANIAL BERRY ANEURYSMS REGARDLESS OF THEIR POST-ICTUS NEUROLOGICAL CONDITION
ODE-47 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA APPROVED TEST.
ODE-48 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA APPROVED TEST
ODE-49 TREATMENT OF MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
ODE-5 FOR SEQUENTIAL USE FOR THE TREATMENT OF CYANIDE POISONING THAT IS JUDGED TO BE LIFE-THREATENING
ODE-50 FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST.
ODE-51 TOPICAL TREATMENT OF STAGE 1A AND 1B MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN-DIRECTED THERAPY
ODE-52 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS AS FIRST-LINE TREATMENT, IN COMBINATION WITH GEMCITABINE.
ODE-53 TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) WHO GROUP 1, TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING.
ODE-54 TX OF PAH TO DELAY DISEASE PROGRESSION. DISEASE PROGRESSION INCLUDED: DEATH, INITIATION OF IV OR SC PROSTANOIDS, OR CLINICAL WORSENING OF PAH (DECREASED 6-MINUTE WALK DISTANCE, WORSENED PAH SYMPTOMS AND NEED FOR ADDITIONAL PAH TREATMENT).
ODE-55 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-56 TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA (DCT) THAT IS REFRACTORY TO RADIOACTIVE IODINE TREATMENT.
ODE-57 TRAMETINIB IN COMBO WITH DABRAFENIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST. THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
ODE-58 DABRAFENIB IN COMBO WITH TRAMETINIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST. THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
ODE-59 TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
ODE-6 FOR THE MANAGEMENT OF POSTHERPETIC NEURALGIA
ODE-60 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-61 TREATMENT OF NEUROGENIC SYMPTOMATIC ORTHOSTATIC HYPOTENSION IN PATIENTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE-BETA-HYDROXYLASE DEFICIENCY, AND NONDIABETIC AUTONOMIC NEUROPATHY
ODE-62 TREATMENT OF PROLIFERATING INFANTILE HEMANGIOMA REQUIRING SYSTEMIC THERAPY.
ODE-63 TREATMENT OF VISCERAL LEISHMANIASIS DUE TO LEISHMANIA DONOVANI; CUTANEOUS LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS, LEISHMANIA GUYANENSIS, AND LEISHMANIA PANAMENSIS; AND MUCOSAL LEISHMANIASIS DUE TO LEISHMANIA BRAZILIENSIS.
ODE-64 SELECTIVE HEPATIC INTRA-ARTERIAL USE FOR IMAGING TUMORS IN ADULTS WITH KNOWN HEPATOCELLULAR CARCINOMA (HCC)
ODE-65 TREATMENT OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA AS PART OF A COMBINATION REGIMEN.
ODE-66 TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB.
ODE-67 GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
ODE-68 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
ODE-69 TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK
ODE-7 TO REDUCE THE RISK OF PRETERM BIRTH IN WOMEN WITH SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH
ODE-70 RELAPSED CLL, IN COMBO. WITH RITUXIMAB, IN PATIENTS FOR WHOM RITUXIMAB ALONE WOULD BE CONSIDERED APPROPRIATE THERAPY DUE TO OTHER CO-MORBIDITIES; AND RELAPSED SLL IN PATIENTS WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES
ODE-71 RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA (FL) IN PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR SYSTEMIC THERAPIES
ODE-72 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY
ODE-73 LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS (EMS), INTERMEDIATE METABOLIZERS (IMS), OR POOR METABOLIZERS (PMS) AS DETECTED BY AN FDA-CLEARED TEST.
ODE-74 TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY
ODE-75 TREATMENT OF PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY.
ODE-76 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE NOT RECEIVED AT LEAST 1 PRIOR THERAPY
ODE-77 TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
ODE-78 TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY.
ODE-79 TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
ODE-8 TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO ARE UNABLE TO UNDERGO PARATHYROIDECTOMY
ODE-80 TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S
ODE-81 TREATMENT OF PATIENTS WITH ACROMEGALY WHO HAVE HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
ODE-82 TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL
ODE-83 USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
ODE-84 TREATMENT OF MOTOR FLUCTUATIONS IN PATIENTS WITH ADVANCED PARKINSON'S DISEASE
ODE-85 AS A REPLACEMENT SOLUTION IN CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND IN CASE OF DRUG POISONING WHEN CRRT IS USED TO REMOVE DIALYZABLE SUBSTANCES
ODE-86 TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
ODE-87 TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE REFRACTORY DIFFERENTIATED THYROID CANCER
ODE-88 FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE TREATMENT)
ODE-89 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR REGIMENS, INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT
ODE-9 TREATMENT OF ASYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE
ODE-90 TREATMENT OF INVASIVE MUCORMYCOSIS IN PATIENTS 18 YEARS OF AGE AND OLDER
ODE-91 TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS
ODE-92 TREATMENT OF LYMPHANGIOLEIOMYOMATOSIS (LAM)
ODE-93 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 YEARS AND OLDER WHO ARE HOMOZYGOUS FOR F508DEL MUTATION IN THE CFTR GENE
ODE-94 PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY TRANSPLANT PATIENTS CONVERTED FROM TACROLIMUS IMMEDIATE-RELEASE FORMULATIONS IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS
ODE-95 FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
ODE-96 TREATMENT OF PRIMARY HYPERKALEMIC PERIODIC PARALYSIS, PRIMARY HYPOKALEMIC PERIOD PARALYSIS, AND RELATED VARIANTS
ODE-97 TO EXPAND THE INDICATION TO PEDIATRIC PATIENTS 2-6 YEARS OF AGE WITH NEPHROPATHIC CYSTINOSIS
ODE-98 TREATMENT OF HEREDITARY OROTIC ACIDURIA
ODE-99 FOR USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN, FOR THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED FOLLOWING GEMCITABINE-BASED THERAPY

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