| 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-172 |
ADDITION OF A ONCE WEEKLY DOSING REGIMEN FOR CARFILZOMIB IN COMBINATION WITH DEXAMETHASONE FOR PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY |
| D-173 |
DOSING RECOMMENDATION FOR THE USE OF ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FIXED DOSE COMBINATION IN HIV-1 INFECTED ADULT PATIENTS WITH END-STAGE-RENAL DISEASE WHO ARE RECEIVING CHRONIC HEMODIALYSIS |
| D-174 |
MODIFICATIONS TO THE EXISTING DOSING REGIMEN TO ALLOW FOR TREATMENT INTERRUPTIONS OF UP TO 8 WEEKS FOR INTOLERABLE ADVERSE REACTIONS |
| D-175 |
EIGHT-WEEK DOSING REGIMEN FOR THE TREATMENT OF GENOTYPES 1, 2, 3, 4, 5, AND 6, CHRONIC HEPATITIS C VIRUS INFECTION IN TREATMENT-NAIVE SUBJECTS WITH COMPENSATED CIRRHOSIS BASED ON THE RESULTS FROM THE EXPEDITION-8 STUDY |
| D-176 |
IBRUTINIB IN COMBINATION WITH RITUXIMAB |
| D-177 |
INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS |
| D-18 |
LOWER RECOMMENDED STARTING DOSE GUIDELINES |
| D-181 |
DOSING REGIMEN EXTENDING THE CONTRACEPTION USE FROM 5 YEARS TO UP TO 6 YEARS |
| D-182 |
NEW DOSING REGIMEN FOR THE PREVENTION AND MANAGEMENT OF NERATINIB‐ASSOCIATED DIARRHEA |
| D-183 |
3-DAY DOSING REGIMEN FOR THE TREATMENT OF COVID-19 IN ADULTS AND PEDIATRIC PATIENTS (>12 YEARS AND WEIGHING AT LEAST 40 KG) WITH POSITIVE RESULTS OF DIRECT SARS-COV-2 VIRAL TESTING, WHO ARE NOT HOSPITALIZED AND HAVE MILD-TO-MODERATE COVID-19, AND ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH |
| D-184 |
NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS |
| D-185 |
ADDITION OF A 3RD MAINTENANCE DOSE OF SEMAGLUTIDE |
| D-186 |
ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING |
| D-187 |
ADDITION OF SECOND DOSE FOR TREATMENT OF PRESBYOPIA IN ADULTS |
| D-188 |
USE OF ALTERNATE INITIAL DOSING REGIMEN FOR INITIATION OF LACOSAMIDE TREATMENT IN PARTIAL ONSET SEIZURE PATIENTS ≥1 MONTH TO <17 YEARS OF AGE AND IN PRIMARY GENERALIZED TONIC-CLONIC SEIZURE PATIENTS ≥4 TO <17 YEARS |
| D-189 |
EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE |
| 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-776 |
FIRSTLINE MAINTENANCE TX IN PTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE, SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA WHO ARE IN COMPLETE OR PARTIAL RESPONSE TO FIRSTLINE PLATINUM-BASED CHEMOTHERAPY |
| 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-788 |
NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD) |
| I-789 |
VENETOCLAX IN COMBO WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| I-79 |
MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM |
| I-790 |
USE OF FERRIC CITRATE FOR THE TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH CKD NOT ON DIALYSIS |
| I-791 |
TREATMENT OF PEDIATRIC PATIENTS ONE YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE (PH+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| I-792 |
TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB |
| I-793 |
TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE |
| I-794 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY |
| I-795 |
VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
| I-796 |
USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL) |
| I-797 |
USED IN COMBINATION WITH A RITUXIMAB PRODUCT, ARE INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL) |
| I-798 |
TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) |
| I-799 |
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER |
| 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-800 |
TREATMENT OF OCULAR INFLAMMATION FOLLOWING OPHTHALMIC SURGERY |
| I-801 |
USE IN CARDIAC MRI TO ASSESS MYOCARDIAL PERFUSION (STRESS, REST) AND LATE GADOLINIUM ENHANCEMENT IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CORONARY ARTERY DISEASE (CAD) |
| I-802 |
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT |
| I-803 |
TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| I-804 |
EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS |
| I-805 |
SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE |
| I-806 |
EXPANDED INDICATION FOR PTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HX OF TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W RESISTANCE TO DORAVIRINE, LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE |
| I-807 |
TREATMENT OF ADVANCED ENDOMETRIAL CARCINOMA THAT IS NOT MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT, WHO HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION |
| I-808 |
TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) |
| I-809 |
TO REDUCE THE RISK OF END-STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND DIABETIC NEPHROPATHY WITH ALBUMINURIA > 300 MG/DAY |
| I-81 |
PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF OROPHARYNGEAL CANDIDIASIS |
| I-810 |
PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING |
| I-811 |
TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 12 YEARS OF AGE OR OLDER, WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 48 HOURS AND ARE AT HIGH RISK OF DEVELOPING INFLUENZA-RELATED COMPLICATIONS |
| I-812 |
FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINAL SEX |
| I-813 |
TX OF ADULT PTS W/ ADV OVARIAN FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & ASSOCIATED W/ HRD DEFICIENCY POSITIVE STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| I-814 |
TX OF ADV OVARIAN FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & ASSOCIATED W/ HRD DEFICIENCY DEFINED BY POSITIVE STATUS GENOMIC INSTABILITY & WHO HAVE PROGRESSED >6MO AFTER RESPONSE TO LAST PLATINUM-BASED CHEMO |
| I-815 |
TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA (CABP) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS |
| I-816 |
TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| I-817 |
TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| I-818 |
MAINTENANCE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DISEASE HAS NOT PROGRESSED ON AT LEAST 16 WEEKS OF A FIRST-LINE PLATINUM-BASED CHEMOTHERAPY REGIMEN |
| I-819 |
ADJUNCT TO MAX TOLERATED STATIN TX TO REDUCE RISK OF MI, STROKE, CORONARY REVASCULARIZATION, & UNSTABLE ANGINA REQUIRING HOSPITALIZATION IN ADULTS W/ ELEVATED TG LEVELS & ESTABLISHED CV DISEASE OR DIABETES MELLITUS & 2+ RISK FACTORS FOR CV DISEASE |
| I-82 |
TREATMENT OF TRAVELERS' DIARRHEA |
| I-820 |
INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION |
| I-821 |
TREATMENT OF CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA PERITONITIS AND ABSCESSES WITHOUT MENINGOENCEPHALITIS AND/OR OCULAR DISSEMINATION IN PEDIATRIC PATIENTS YOUNGER THAN 4 MONTHS OF AGE |
| I-822 |
REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION OR NON-FATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE |
| I-823 |
USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING |
| I-824 |
RIVAROXABAN IN COMBINATION WITH ASPIRIN, IS INDICATED TO REDUCE THE RISK OF MAJOR CV EVENTS (CV DEATH, MI, AND STROKE) IN PATIENTS WITH CHRONIC CORONARY ARTERY DISEASE (CAD) OR PERIPHERAL ARTERY DISEASE (PAD) |
| I-825 |
TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE |
| I-826 |
ENCORAFENIB, IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULTPATIENTS WITH METASTATIC COLORECTAL CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY |
| I-827 |
EXPANDED INDICATION FOR PATIENTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO DORAVIRINE |
| I-828 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| I-829 |
TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY (CPP) |
| I-83 |
ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN |
| I-830 |
TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR-DIRECTED THERAPY AND A TAXANE-BASED CHEMOTHERAPY |
| I-831 |
W/BEVACIZUMAB FOR MAINTENANCE TX OF ADULTS W/ADV. EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMO & CA ASSOCIATED W/ HOMOLOGOUS RECOMBINATION DEFICIENCY POSITIVE STATUS |
| I-832 |
TX OF ADULT PTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC HOMOLOGOUS RECOMBINATION REPAIR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT WITH ENZALUTAMIDE OR ABIRATERONE |
| I-833 |
MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| I-834 |
TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE (NYHA CLASS II-IV) WITH REDUCED EJECTION FRACTION |
| I-835 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) WHOSE TUMORS ARE POSITIVE FOR AN EZH2 MUTATION AS DETECTED BY AN FDA-APPROVED TEST AND WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES |
| I-836 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL) WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
| I-837 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY |
| I-838 |
TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY (DPN) OF THE FEET |
| I-839 |
TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE |
| I-84 |
INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION |
| I-840 |
TREATMENT OF SYMPTOMS IN ADULTS WITH MAJOR DEPRESSIVE DISORDER (MDD) WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR. |
| I-841 |
TO REDUCE THE RISK OF HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE OR MULTIPLE CARDIOVASCULAR RISK FACTORS |
| I-842 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE LINES OF THERAPY IN COMBINATION WITH DARATUMUMAB AND DEXAMETHASONE |
| I-843 |
MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS AGED 18 YEARS AND OLDER |
| I-844 |
INDICATED IN PATIENTS 18 YEARS OF AGE AND OLDER FOR THE TREATMENT OF HOSPITAL ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) CAUSED BY THE FOLLOWING SUSCEPTIBLE GRAM-NEGATIVE MICROORGANISMS: ACINETOBACTER BAUMANNII COMPLEX, ESCHERICHIA COLI, ENTEROBACTER CLOACAE COMPLEX, KLEBSIELLA PNEUMONIAE, PSEUDOMONAS AERUGINOSA, AND SERRATIA MARCESCENS |
| I-845 |
TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST |
| I-846 |
TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
| I-847 |
EXPANDED INDICATION OF THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST |
| I-848 |
REDUCE THE RISK OF STROKE IN PATIENTS WITH ACUTE ISCHEMIC STROKE (NIH STROKE SCALE SCORE <=5) OR HIGH-RISK TRANSIENT ISCHEMIC ATTACK (TIA) |
| I-849 |
CHRONIC PHASE (CP) CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO AT LEAST TWO PRIOR KINASE INHIBITORS |
| I-85 |
TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS |
| I-850 |
TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER |
| I-851 |
TO REDUCE THE RISK OF A FIRST MYOCARDIAL INFARCTION (MI) OR STROKE IN PATIENTS WITH CORONARY ARTERY DISEASE (CAD) AT HIGH RISK FOR SUCH EVENTS |
| I-852 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE |
| I-853 |
INDICATION OF OSIMERTINIB AS ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH 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 |
| I-854 |
FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB |
| I-855 |
TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 3 YEARS AND OLDER AND WEIGHING 35 KILOGRAMS OR MORE |
| I-856 |
INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY |
| I-857 |
TO REDUCE THE RISK OF SUSTAINED EGFR DECLINE, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION |
| I-858 |
FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER |
| I-859 |
TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS |
| I-86 |
TREATMENT OF SECONDARY CARNITINE DEFICIENCY |
| I-860 |
FOR THE TREATMENT OF MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN ADULT PATIENTS |
| I-861 |
TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG |
| I-862 |
TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED |
| I-863 |
TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM), INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) AND SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN) |
| I-864 |
TREATMENT OF ADULT PATIENTS WITH MAST CELL LEUKEMIA (MCL) |
| I-865 |
FOR THE PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS |
| I-866 |
FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS |
| I-867 |
INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD |
| I-868 |
LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC) |
| I-869 |
REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION |
| I-87 |
RENAL IMAGING AGENT FOR USE IN CHILDREN |
| I-870 |
INDICATED FOR THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS |
| I-871 |
TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM) |
| I-872 |
ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER |
| I-873 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC DIFFERENTIATED THYROID CANCER (DTC) THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY OR INELIGIBLE |
| I-874 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN |
| I-875 |
FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN IDH1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
| I-876 |
TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS |
| I-877 |
INDICATION FOR THE USE OF ABEMACICLIB IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE, NODE-POSITIVE, EARLY CANCER (EBC) AT HIGH RISK OF RECURRENCE AND A KI-67 SCORE>20% AS DETERMINED BY AN FDA APPROVED TEST |
| I-878 |
ADDITION OF A NEW INDICATION FOR ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER |
| I-879 |
TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS, TO THE PRESCRIBING INFORMATION |
| I-88 |
MANAGEMENT OF ENDOMETRIOSIS |
| I-880 |
TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
| I-881 |
FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS 13 YEARS OF AGE AND OLDER |
| I-882 |
INDICATED FOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I OR II DISORDER (BIPOLAR DEPRESSION) IN ADULTS, AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE |
| I-883 |
TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH REFRACTORY, MODERATE-TO-SEVERE ATOPIC DERMATITIS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH OTHER SYSTEMIC DRUG PRODUCTS, INCLUDING BIOLOGICS, OR WHEN USE OF THOSE THERAPIES ARE INADVISABLE |
| I-884 |
REVISIONS TO THE LABELING TO INCLUDE DATA FOR SUBJECTS WITH MILD TO MODERATE PLAQUE PSORIASIS, AND TO ALLOW FOR AN EXPANSION OF THE INDICATION |
| I-885 |
FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GBRCA MUTATED HER2-NEGATIVE HIGH-RISK EARLY BREAST CANCER WHO HAVE PREVIOUSLY BEEN TREATED WITH NEOADJUVANT OR ADJUVANT CHEMOTHERAPY |
| I-886 |
TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
| I-887 |
INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER |
| I-888 |
TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
| I-889 |
TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
| I-89 |
EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE |
| I-890 |
TREATMENT OF ADULT PATIENTS WITH SEVERE ALOPECIA AREATA |
| I-891 |
TREATMENT OF COVID-19 IN HOSPITALIZED ADULTS REQUIRING SUPPLEMENTAL OXYGEN, NONINVASIVE OR INVASIVE MECHANICAL VENTILATION, OR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) |
| I-892 |
CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGEAND OLDER WITH BARDET-BIEDL SYNDROME (BBS) |
| I-893 |
IN COMBINATION WITH AZACITIDINE OR AS MONOTHERAPY FOR THE TREATMENT OFNEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| I-894 |
DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
| I-895 |
TRAMETINIB IS INDICATED IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
| I-896 |
INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| I-897 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE |
| I-898 |
FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
| I-899 |
TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT |
| I-9 |
PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING |
| I-90 |
INTENSIVE CARE UNIT SEDATION |
| I-900 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC HORMONE‐SENSITIVE PROSTATE CANCER (MHSPC) IN COMBINATION WITH DOCETAXEL |
| I-901 |
EXPANDED INDICATION TO INCLUDE LOWERING OF PLASMA OXALATE LEVELS INADULT AND PEDIATRIC PATIENTS WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) |
| I-902 |
TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS |
| I-903 |
REDUCTION IN THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) INADULT AND POST-MENARCHAL PEDIATRIC FEMALES |
| I-904 |
ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVEDISORDER IN ADULTS |
| I-905 |
ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT AND NONMALIGNANTPULMONARY LESIONS IN ADULT PATIENTS WITH KNOWN OR SUSPECTED CANCER IN THE LUNG |
| I-906 |
TUCATINIB IN COMBINATION WITH TRASTUZUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE, UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY |
| I-907 |
TO INCREASE BONE DENSITY IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE (DEFINED AS A HISTORY OF OSTEOPOROTIC FRACTURE OR MULTIPLE RISK FACTORS FOR FRACTURE), OR PATIENTS WHO HAVE FAILED OR ARE INTOLERANT TO OTHER AVAILABLE OSTEOPOROSIS THERAPY |
| I-908 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY |
| I-909 |
PREVENTIVE TREATMENT OF MIGRAINE IN ADULTS |
| I-91 |
MONOTHERAPY USE FOR HYPERTENSION |
| I-910 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY |
| I-911 |
FOR FLUORESCENCE IMAGING OF LYMPH NODES AND DELINEATION OF LYMPHATIC VESSELS DURINGLYMPHATIC MAPPING IN ADULTS WITH BREAST CANCER FOR WHICH THIS PROCEDURE IS A COMPONENT OF INTRAOPERATIVEMANAGEMENT |
| I-912 |
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM) |
| I-913 |
TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE |
| I-914 |
IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THETREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) |
| I-915 |
TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY |
| I-916 |
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) |
| I-917 |
TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR UP TO 5 YEARS IN PATIENTS WHO CHOOSE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION |
| I-918 |
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| I-919 |
TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
| I-92 |
ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE |
| I-920 |
USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITHHOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC). |
| I-921 |
TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE |
| 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-232 |
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES |
| M-233 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE FIXED-DOSE COMBINATION OF TIOTROPIUM BROMIDE AND OLODATEROL TO INCLUDE REDUCTION OF COPD EXACERBATIONS |
| M-234 |
UPDATE TO THE PRESCRIBING INFORMATION FOR VORTIOXETINE ON TREATMENT-EMERGENT SEXUAL DYSFUNCTION COMPARING VORTIOXETINE AND SSRIS |
| M-235 |
INFORMATION ADDED TO SECTION 14 OF THE LABELING TO DESCRIBE STUDY LAP016A2307 TO FULFILL POSTMARKETING STUDY REQUIREMENT 1586-1 |
| M-236 |
INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB |
| M-237 |
INFORMATION ADDED TO LABELING TO DESCRIBE A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARENICLINE FOR SMOKING CESSATION IN ADOLESCENT SMOKERS |
| M-238 |
INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO REFLECT THAT NO DOSE ADJUSTMENT IS NEEDED FOR PATIENTS WITH AN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) OF 45 ML/MIN/1.73 M2 OR GREATER AS SUPPORTED BY CLINICAL STUDY REPORT |
| M-239 |
INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A TRIAL CONDUCTED IN TREATMENT NAIVE PEDIATRIC PATIENTS, AGES 2 YEARS TO < 18 YEARS WITH TRANSFUSIONAL IRON OVERLOAD |
| M-24 |
INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC SAFETY INFORMATION |
| M-240 |
INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES |
| M-241 |
INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD |
| M-242 |
INFORMATION ADDED TO THE LABELING REGARDING THE EFFICACY AND SAFETY OF INSULIN DEGLUDEC/LIRAGLUTIDE VS INSULIN GLARGINE IN PTS W/ TYPE 2 DIABETES INADEQUATELY CONTROLLED ON SGLT2I WITH OR WITHOUT ORAL ANTIDIABETIC THERAPIES |
| M-243 |
INFORMATION ADDED TO LABELING FROM PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLIND EVALUATOR (PROBE) STUDY EVALUATING THE EFFICACY AND SAFETY OF LOW MOLECULAR WEIGHT HEPARIN/EDOXABAN VERSUS DALTEPARIN IN VENOUS THROMBOEMBOLISM ASSOCIATED WITH CANCER |
| M-244 |
INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS |
| M-245 |
ADDITIONAL INFORMATION ADDED TO THE LABELING BASED ON SAFETY AND EFFICACY DATA FROM THE IMPACT TRIAL |
| M-246 |
ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN |
| M-247 |
REVISIONS TO THE LABELING REGARDING CONTINUOUS SUBCUTANEOUS INSULIN INFUSION AS A CONDITION OF USE FOR INSULIN ASPART |
| M-248 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE |
| M-249 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY LVM-MD-15 TO FULFILL POSTMARKETING COMMITMENT 1943-4 |
| M-25 |
ADDITIONAL SAFETY AND PHARMACOKINETICS INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF AGE ADDED TO PACKAGE INSERT |
| M-250 |
REVISIONS TO THE PEDIATRIC USE SECTION TO INCLUDE AN OPEN-LABEL CLINICAL TRIAL TO FULFILL PMR 1655-1 |
| M-251 |
INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING INFLUENZA VIRUS RESISTANCE TO OSELTAMIVIR IN IMMUNOCOMPROMISED PATIENTS |
| M-252 |
ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME |
| M-253 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY P061, A RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-SITE, DOUBLE-BLIND STUDY TO EVALUATE SAFETY AND EFFICACY OF SUVOREXANT FOR THE TREATMENT OF INSOMNIA IN SUBJECTS WITH ALZHEIMERS DISEASE |
| M-254 |
INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS AGES 7 TO 17 YEARS OF AGE WITH MAJOR DEPRESSIVE DISORDER |
| M-255 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4018 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALAFENAMIDE |
| M-256 |
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION TO FULFILL A POST-MARKETING REQUIREMENT |
| M-257 |
INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE USE OF PLAQUE PSORIASIS OF THE SCALP |
| M-258 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4 |
| M-259 |
INFORMATION ADDED TO THE LABELING REGARDING SAFETY AND EFFICACY IN SUBJECTS WITH HCV SUBTYPE 3B INFECTION |
| 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-260 |
INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS |
| M-261 |
ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS |
| M-262 |
REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P146 TO FULFILL THE REQUIREMENTS OF PMR 3003-4 |
| M-263 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3 |
| M-264 |
INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT |
| M-265 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
| M-266 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE STUDY GS-US-320-4035 IN VIROLOGICALLY SUPPRESSED ADULTS W/ CHRONIC HEP B INFECTION WHO SWITCHED FROM TENOFOVIR DISOPROXIL FUMARATE TO TENOFOVIR ALFAENAMIDE |
| M-267 |
INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY LUAA21004-402 |
| M-268 |
ADDITION OF INFORMATION TO THE LABEL REGARDING A CLEAR PRODUCT PRESENTATION AND 26 ML VOLUME PRODUCTS |
| M-269 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1 |
| M-27 |
INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY |
| M-270 |
INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION |
| M-271 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDYHRA2914-5016 |
| M-272 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1 |
| M-273 |
REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M |
| M-274 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY CBAF312A2130 |
| M-275 |
REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV |
| M-276 |
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTSFROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST |
| M-277 |
UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
| M-278 |
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665 |
| M-279 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF FIGARO-DKD STUDY |
| M-28 |
INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL CONDITION |
| M-280 |
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDIES E7389-G000-223 AND E7389-G000-213, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST |
| M-281 |
REVISIONS TO THE LABELING TO PROVIDE FOR THE EXPANSION OF THE USE OF STIRIPENTOL FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS TAKING CLOBAZAM TO INCLUDE PEDIATRIC PATIENTS WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE |
| M-282 |
REVISIONS TO THE LABELING TO ADD THE RESULTS OF A CLINICAL STUDY (TA-303) IN PATIENTS WITH ED FOLLOWING BILATERAL NERVE-SPARING RADICAL PROSTATECTOMY |
| M-283 |
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HESTIA3 |
| M-284 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM GALILEO TRIAL |
| M-285 |
REVISIONS TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULTS OF STUDY INCB 18424-269 |
| M-286 |
INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM STUDY ORGN001-102 |
| M-287 |
LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17) |
| M-288 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF STUDY APL2-308 |
| M-289 |
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 |
| M-29 |
LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN ADOLESCENTS AGED 12 TO 16 YEARS |
| M-290 |
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OFSTUDY HZA114971 |
| M-291 |
REVISIONS TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE PACKAGE INSERT TO INCLUDE THE RESULT OF STUDY P145 |
| M-292 |
REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815 |
| M-293 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113 |
| M-294 |
INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860 |
| M-295 |
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST |
| M-296 |
REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM PROTOCOL 1218- 0091 |
| M-297 |
LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY MYK-461-017 |
| M-298 |
LABELING REVISIONS RELATED TO STUDY D1699CC00001 |
| M-299 |
CLINICAL STUDY INFORMATION ADDED TO THE LABEL ABOUT THE TREATMENT OF MODERATE TO SEVERE GENITAL PSORIASIS |
| 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-300 |
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY SYR-322-309, CONDUCTED IN RESPONSE TO A PEDIATRIC WRITTEN REQUEST |
| M-301 |
CLINICAL STUDY INFORMATION ADDED TO LABEL ABOUT THE TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN PATIENTS WITH SEVERELY REDUCED RENAL FUNCTION (ESTIMATED GLOMERULAR FILTRATION RATE, EGFR < 30 ML/MIN) |
| 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-206 |
FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-207 |
TREATMENT OF STATUS EPILEPTICUS IN ADULTS |
| ODE-208 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES |
| ODE-209 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) AFTER AT LEAST TWO PRIOR SYSTEMIC THERAPIES |
| ODE-21 |
AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY |
| ODE-210 |
INDICATED IN COMBINATION WITH STANDARD IMMUNOSUPPRESSIVE THERAPY FOR THE FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA |
| ODE-211 |
INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| ODE-212 |
INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS |
| ODE-213 |
INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-214 |
TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY |
| ODE-215 |
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC RECEPTOR TYROSINE KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION |
| ODE-216 |
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| ODE-217 |
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DIESASE |
| ODE-218 |
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON ALECTINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE |
| ODE-219 |
INDICATED FOR THE TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE DISEASE HAS PROGRESSED ON CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE |
| 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-220 |
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY |
| ODE-221 |
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE NO SATISFACTORY ALTERNATIVE TREATMENTS OR THAT HAVE PROGRESSED FOLLOWING TREATMENT |
| ODE-222 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WHO HAVE RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A FMS-LIKE TYROSINE KINASE 3 (FLT3) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-223 |
TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) |
| ODE-224 |
INDICATED, IN COMBINATION WITH LOW-DOSE CYTARABINE, FOR THE TREATMENT OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULT PATIENTS WHO ARE >=75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| ODE-225 |
INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| ODE-226 |
MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| ODE-227 |
INDICATED FOR TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB |
| ODE-228 |
INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER |
| ODE-229 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY |
| ODE-23 |
ADVANCED SOFT TISSUE SARCOMA (STS) WHO HAVE RECEIVED PRIOR CHEMOTHERAPY |
| ODE-230 |
FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-231 |
INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY |
| ODE-232 |
TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1,2,3,4,5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A) |
| ODE-233 |
TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER OR WEIGHING AT LEAST 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH |
| ODE-234 |
INDICATED FOR THE TREATMENT OF STABLE SYMPTOMATIC HEART FAILURE DUE TO DILATED CARDIOMYOPATHY (DCM) IN PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER, WHO ARE IN SINUS RHYTHM WITH AN ELEVATED HEART RATE |
| ODE-235 |
INDICATED FOR THE TREATMENT OF ACUTE HERPETIC KERATITIS (DENDRITIC ULCERS) IN PATIENTS WITH HERPES SIMPLEX (HSV-1 AND HSV-2) VIRUS |
| ODE-236 |
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 MONTHS TO LESS THAN 12 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA |
| ODE-237 |
TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION |
| ODE-238 |
TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER |
| ODE-239 |
TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| ODE-24 |
TREATMENT OF ADULTS WITH RENAL ANGIOMYOLIPOMA AND TUBEROUS SCLEROSIS COMPLEX (TSC) NOT REQUIRING IMMEDIATE SURGERY |
| ODE-240 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT |
| ODE-241 |
INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL) |
| ODE-242 |
TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULT PTS WHO ARE >=75 YRS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| ODE-243 |
ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E., SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER |
| ODE-244 |
TREATMENT OF LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) IN PATIENTS 6 TO LESS THAN 17 YEARS OF AGE |
| ODE-245 |
INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL) |
| ODE-246 |
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT |
| ODE-247 |
TX OF PTS W/ CYSTIC FIBROSIS (CF) AGE 6 TO <12 YRS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION OR W/ AT LEAST 1 MUTATION IN CF TRANSMEMBRANE CONDUCTANCE REGULATORY GENE RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND/OR CLINICAL EVIDENCE |
| ODE-248 |
TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCETS DISEASE |
| ODE-249 |
TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS (CF) AGE 6 YEARS TO LESS THAN 12 YEARS WHO ARE HOMOZYGOUS FOR F508DEL MUTATION OR WHO HAVE AT LEAST ONE MUTATION IN THE CF TRANSMEMBRANE CONDUCTANCE REGULATOR GENE THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR |
| ODE-25 |
MANAGEMENT OF POSTHERPETIC NEURALGIA IN ADULTS. |
| ODE-250 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY |
| ODE-251 |
INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 30 KG) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS |
| ODE-252 |
TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE |
| ODE-253 |
INDICATED AS PART OF A COMBINATION REGIMEN WITH BEDAQUILINE AND LINEZOLID FOR THE TREATMENT OF ADULTS WITH PULMONARY EXTENSIVELY DRUG RESISTANT (XDR) OR TREATMENT-INTOLERANT OR NONRESPONSIVE MULTIDRUG-RESISTANT (MDR) TUBERCULOSIS (TB) |
| ODE-254 |
INDICATED TO IMPROVE WAKEFULNESS IN ADULT PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH NARCOLEPSY |
| ODE-255 |
INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY |
| ODE-256 |
FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF |
| ODE-257 |
IN COMBO W/ DEXAMETHASONE FOR ADULTS W/ RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO RECEIVED AT LEAST 4 PRIOR THERAPIES AND REFRACTORY TO AT LEAST 2 PROTEASOME INHIBITORS, AT LEAST 2 IMMUNOMODULATORY AGENTS, AND AN ANTI-CD38 MONOCLONAL ANTIBODY |
| ODE-258 |
FOR THE TREATMENT OF CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 2 OR 3 INFECTION IN PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| ODE-259 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH INTERMEDIATE-2 OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) |
| ODE-26 |
TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS |
| ODE-260 |
INDICATED TO INCREASE SYSTEMIC EXPOSURE OF ATAZANAVIR IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35 KG |
| ODE-261 |
INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) |
| ODE-262 |
TREATMENT OF PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS |
| ODE-263 |
TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN |
| ODE-264 |
TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN |
| ODE-265 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE |
| ODE-266 |
ADULT & PED >=12YRS OLD W/ SOLID TUMORS THAT HAVE NTRK W/O KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY & HAVE EITHER PROGRESSED FOLLOWING TX OR HAVE NO SATISFACTORY ALTERNATIVE TX |
| ODE-267 |
INDICATED IN COMBINATION WITH HIGH FLUID INTAKE, ALKALI, AND DIET MODIFICATION, FOR THE PREVENTION OF CYSTINE STONE FORMATION IN PEDIATRIC PATIENTS 20KG TO 9 YEARS OF AGE W/SEVERE HOMOZYGOUS CYSTINURIA, WHO ARE NOT RESPONSIVE TO THESE MEASURES ALONE |
| ODE-268 |
INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| ODE-269 |
PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY TRANSPLANT, LIVER TRANSPLANTS, AND HEART TRANSPLANT, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
| 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-270 |
INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) |
| ODE-271 |
INDICATED IN COMBINATION WITH OTHER ANTI-MYELOMA PRODUCTS FOR THE TREATMENT OF ADULTS WITH MULTIPLE MYELOMA (MM) |
| ODE-272 |
INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION |
| ODE-273 |
INDICATED FOR THE TREATMENT OF ADULTS WITH ACUTE HEPATIC PORPHYRIA (AHP) |
| ODE-274 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| ODE-275 |
INDICATED FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE |
| ODE-276 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| ODE-277 |
TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
| ODE-278 |
TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY GENOMIC INSTABILITY & PROGRESSED >6 MONTHS AFTER RESPONSE TO THE LAST PLATINUM-BASED CHEMOTHERAPY |
| ODE-279 |
INDICATED FOR THE ACUTE TX OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY (I.E. SEIZURE CLUSTERS, ACUTE REPETITIVE SEIZURES) THAT ARE DISTINCT FROM A PATIENT’S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 6 YEARS OF AGE AND OLDER |
| 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-280 |
INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING |
| ODE-281 |
INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| ODE-282 |
INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM) |
| ODE-283 |
MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC |
| ODE-284 |
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG |
| ODE-285 |
IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG |
| ODE-286 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| ODE-287 |
TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) |
| ODE-288 |
INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) |
| ODE-289 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER (LG-UTUC) |
| ODE-29 |
LOCALIZATION OF LYMPH NODES DRAINING A PRIMARY TUMOR IN PATIENTS WITH MELANOMA WHEN USED WITH A HAND-HELD GAMMA COUNTER |
| ODE-290 |
INDICATED FOR THE INITIAL TREATMENT OF SEVERE MALARIA IN ADULT AND PEDIATRIC PATIENTS TO ALWAYS BE FOLLOWED BY A COMPLETE TREATMENT COURSE OF AN APPROPRIATE ORAL ANTIMALARIAL REGIMEN |
| ODE-291 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-292 |
INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-293 |
TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| ODE-294 |
PROPHYLAXIS OF ORGAN REJECTION IN PEDIATRIC PATIENTS RECEIVING ALLOGENEIC KIDNEY OR HEART TRANSPLANTS, IN COMBINATION WITH OTHER IMMUNOSUPPRESSANTS |
| ODE-295 |
INDICATED FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY |
| ODE-296 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH AIDS-RELATED KAPOSI SARCOMA (KS) AFTER FAILURE OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) |
| ODE-297 |
FOR THE TREATMENT OF KAPOSI SARCOMA (KS) IN ADULT PATIENTS WHO ARE HIV-NEGATIVE |
| ODE-298 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE RECEIVED PRIOR TREATMENT WITH 3 OR MORE KINASE INHIBITORS, INCLUDING IMATINIB |
| ODE-299 |
INDICATED FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS AGED 16 YEARS AND OLDER WITH METASTATIC OR LOCALLY ADVANCED EPITHELIOID SARCOMA NOT ELIGIBLE FOR COMPLETE RESECTION |
| 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-300 |
FOR THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST, NOT INCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB |
| ODE-301 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) |
| ODE-302 |
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY |
| ODE-303 |
ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE) |
| ODE-304 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| ODE-305 |
TREATMENT OF INVASIVE ASPERGILLOSIS |
| ODE-306 |
W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY |
| ODE-307 |
INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS 5 YEARS AND OLDER TO LESS THAN 12 YEARS OF AGE AND WEIGHING AT LEAST 15 KG WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB) |
| ODE-308 |
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE CAPACITY |
| ODE-309 |
INDICATED FOR USE IN COMBINATION WITH TRASTUZUMAB AND CAPECITABINE FOR TREATMENT OF ADULT PATIENTS WITH METASTATIC HER2-POSITIVE BREAST CANCER AND BRAIN METASTASES, WHO HAVE RECEIVED ONE OR MORE PRIOR ANTI-HER2-BASED REGIMENS IN THE METASTIC SETTING |
| ODE-31 |
TREATMENT OF CORNEAL CYSTINE CRYSTAL ACCUMULATION IN PATIENTS WITH CYSTINOSIS |
| ODE-310 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY |
| ODE-311 |
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) |
| ODE-312 |
INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER |
| ODE-313 |
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTENACE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE EITHER PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY |
| ODE-314 |
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA WHOSE TUMORS ARE POSITIVE FOR AN EZH2 MUTATION AS DETECTED BY AN FDA-APPROVED TEST AND WHO HAVE RECEIVED AT LEAST 2 PRIOR SYSTEMIC THERAPIES, AND FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
| ODE-315 |
FOR CLEANSING OF THE COLON AS A PREPARATION FOR COLONOSCOPY IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| ODE-316 |
TREATMENT OF ADULT PATIENTS WITH MYELODYSPLASTIC SYNDROMES (MDS), INCLUDING PREVIOUSLY TREATED AND UNTREATED, DE NOVO AND SECONDARY MDS WITH THE FOLLOWING FRENCH-AMERICAN-BRITISH SUBTYPES (REFRACTORY ANEMIA, REFRACTORY ANEMIA WITH RINGED SIDEROBLASTS, REFRACTORY ANEMIA WITH EXCESS BLASTS, AND CHRONIC MYELOMONOCYTIC LEUKEMIA [CMML]) AND INTERMEDIATE-1, INTERMEDIATE-2, AND HIGH-RISK INTERNATIONAL PROGNOSTIC SCORING SYSTEM GROUPS. |
| ODE-317 |
FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS |
| ODE-318 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC RET FUSION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST |
| ODE-319 |
INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI |
| 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-320 |
INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY |
| ODE-321 |
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS TO LESS THAN 6 MONTHS WHO HAVE ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA |
| ODE-322 |
TREATMENT OF NARCOLEPSY |
| ODE-323 |
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| ODE-324 |
TREATMENT OF HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) AND PROGEROID LAMINOPATHIES |
| ODE-325 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS |
| ODE-326 |
TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) OR DRAVET SYNDROME (DS) IN PATIENTS BETWEEN 1 AND 2 YEARS OF AGE |
| ODE-327 |
ADD-ON MAINTENANCE THERAPY TO IMPROVE PULMONARY FUNCTION IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WITH CYSTIC FIBROSIS AND WHO HAVE PASSED THE BRONCHITOL TOLERANCE TEST |
| ODE-328 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE |
| ODE-329 |
FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE |
| ODE-33 |
TREATMENT OF PROGRESSIVE, METASTATIC MEDULLARY THYROID CANCER (MTC) |
| ODE-330 |
THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER |
| ODE-331 |
TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY |
| ODE-332 |
TREATMENT OF SEIZURES ASSOCIATED WITH TUBEROUS SCLEROSIS COMPLEX (TSC) IN PATIENTS 1 YEAR OF AGE AND OLDER |
| ODE-333 |
PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| ODE-334 |
TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PATIENTS 2 MONTHS OF AGE AND OLDER |
| ODE-335 |
FOR TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE AT LEAST ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO TEZACAFTOR/IVACAFTOR BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020 |
| ODE-336 |
INDICATED FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH OBESITY DUE TO PROOPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR LEPTIN RECEPTOR (LEPR) DEFICIENCY CONFIRMED BY GENETIC TESTING DEMONSTRATING VARIANTS IN POMC, PCSK1, OR LEPR GENES THAT ARE INTERPRETED AS PATHOGENIC, LIKELY PATHOGENIC, OR OF UNCERTAIN SIGNIFICANCE (VUS) |
| ODE-337 |
FOR ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH 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-338 |
FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGE 4 MONTHS AND OLDER WHO HAVE ONE OF THE ADDITIONAL MUTATIONS IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE THAT HAVE BEEN IDENTIFIED AS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON IN VITRO DATA AND IDENTIFIED IN THE APPROVAL ON DECEMBER 21, 2020 |
| ODE-339 |
TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER URINARY OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS |
| ODE-34 |
TREATMENT OF ADULT PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| ODE-340 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET-MUTANT MEDULLARY THYROID CANCER (MTC) WHO REQUIRE SYSTEMIC THERAPY |
| ODE-341 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE) |
| ODE-342 |
INDICATED TO REDUCE THE RISK OF MORTALITY IN PATIENTS WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A |
| ODE-343 |
FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| ODE-344 |
FOR TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) WHO HAVE RECEIVED AT LEAST THREE PRIOR LINES OF SYSTEMIC THERAPY |
| ODE-345 |
IN PEDIATRIC AND ADULT PATIENTS AS ADJUNCTIVE THERAPY TO STANDARD OF CARE FOR THE TREATMENT OF ACUTE HYPERAMMONEMIA DUE TO PROPIONIC ACIDEMIA (PA) OR METHYLMALONIC ACIDEMIA (MMA) |
| ODE-346 |
FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY, EXCLUDING ADULT PATIENTS COVERED BY XPOVIO'S PREVIOUS INDICATION FOR MULTIPLE MYELOMA APPROVED ON JULY 3, 2019 |
| ODE-347 |
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING |
| ODE-348 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST FOUR PRIOR LINES OF THERAPY AND WHOSE DISEASE IS REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY AGENT, AND ONE CD-38 DIRECTED MONOCLONAL ANTIBODY |
| ODE-349 |
TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST, EXCLUDING PATIENTS WHOSE DISEASE HAS PROGRESSED ON CRIZOTINIB AND AT LEAST ONE OTHER ALK INHIBITOR FOR METASTATIC DISEASE; OR ALECTINIB OR CERITINIB AS THE FIRST ALK INHIBITOR THERAPY FOR METASTATIC DISEASE |
| 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-350 |
TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER |
| ODE-351 |
TREATMENT OF ADULT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) |
| ODE-352 |
TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY |
| ODE-353 |
FOR TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-354 |
TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULT AND PEDIATRIC PATIENTS, INCLUDING NEONATES |
| ODE-355 |
FOR THE TREATMENT OF INVASIVE ASPERGILLOSIS IN ADULTS AND PEDIATRIC PATIENTS 13 YEARS OF AGE AND OLDER |
| ODE-356 |
FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM). ADVSM INCLUDES PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL) |
| ODE-357 |
FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 6 THROUGH 11 YEARS OLD WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| ODE-358 |
FOR THE TREATMENT OF VERNAL KERATOCONJUNCTIVITIS (VKC) IN CHILDREN AND ADULTS |
| ODE-359 |
FOR THE TREATMENT OF BOTH THE FIRST-STAGE (HEMOLYMPHATIC) AND SECOND-STAGE (MENINGOENCEPHALITIC) HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE IN PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 20 KG |
| 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-360 |
FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT AND PEDIATRIC PATIENTS RECEIVING ALLOGENEIC LUNG TRANSPLANT |
| ODE-361 |
INDICATED FOR THE TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PATIENTS 7 YEARS OF AGE AND OLDER WITH NARCOLEPSY |
| ODE-362 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CHRONIC GVHD) AFTER FAILURE OF AT LEAST TWO PRIOR LINES OF SYSTEMIC THERAPY |
| ODE-363 |
TREATMENT OF PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC) |
| ODE-364 |
TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU (VHL) DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA (RCC), CENTRAL NERVOUS SYSTEM (CNS) HEMANGIOBLASTOMAS, OR PANCREATIC NEUORENDOCRINE TUMORS (PNET), NOT REQUIRING IMMEDIATE SURGERY |
| ODE-365 |
TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU (VHL) DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA (RCC), CENTRAL NERVOUS SYSTEM (CNS) HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS (PNET), NOT REQUIRING IMMEDIATE SURGERY |
| ODE-366 |
INDICATED FOR THE TREATMENT OF ADULTS WITH UNRESECTABLE OR METASTATIC GIST HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION, INCLUDING PDGFRA D842V MUTATIONS |
| ODE-367 |
PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD) |
| ODE-368 |
TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-369 |
THE TREATMENT OF IDIOPATHIC HYPERSOMNIA (IH) IN ADULTS |
| ODE-37 |
TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT |
| ODE-370 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN |
| ODE-371 |
TREATMENT OF ADULT PATIENTS WITH WALDENSTRӦM’S MACROGLOBULINEMIA (WM) |
| ODE-372 |
FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5 OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS (CHILD-PUGH A); AND TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE WEIGHING LESS THAN 45 KG WITH HCV GENOTYPE 1 INFECTION, WHO PREVIOUSLY HAVE BEEN TREATED WITH A REGIMEN CONTAINING AN HCV NS5A INHIBITOR OR AN NS3/4A PROTEASE INHIBITOR (PI), BUT NOT BOTH |
| ODE-373 |
TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER |
| ODE-374 |
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 INSERTION MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY |
| ODE-375 |
THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH LOCALLY ADVANCED OR METASTATIC DIFFERENTIATED THYROID CANCER (DTC) THAT HAS PROGRESSED FOLLOWING PRIOR VEGFR-TARGETED THERAPY AND WHO ARE RADIOACTIVE IODINE-REFRACTORY OR INELIGIBLE |
| ODE-376 |
FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN |
| ODE-377 |
AS AN ADJUNCTIVE TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE ANTI-NEUTROPHIL CYTOPLASMIC AUTOANTIBODY (ANCA)-ASSOCIATED VASCULITIS (GRANULOMATOSIS WITH POLYANGIITIS [GPA] AND MICROSCOPIC POLYANGIITIS [MPA]) |
| ODE-378 |
A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY |
| ODE-379 |
FOR TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) 1 YEAR OF AGE AND OLDER |
| ODE-38 |
PART OF COMBINATION THERAPY IN ADULTS (GREATER THAN OR EQUAL TO 18 YEARS) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB) |
| ODE-380 |
TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH ACCELERATED PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) WITH RESISTANCE ORINTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR (TKI) THERAPY |
| ODE-381 |
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION |
| ODE-382 |
TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP), PREVIOUSLY TREATED WITH TWO OR MORE TYROSINE KINASE INHIBITORS (TKIS) |
| ODE-383 |
FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS |
| ODE-384 |
TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OFAGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS |
| ODE-385 |
FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE |
| ODE-386 |
FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) |
| ODE-387 |
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES |
| ODE-388 |
FOR THE TREATMENT OF ADULTS AND PEDIATRIC PATIENTS (12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG) WITH POST-TRANSPLANT CYTOMEGALOVIRUS (CMV) INFECTION/DISEASE THAT IS REFRACTORY TO TREATMENT (WITH OR WITHOUT GENOTYPIC RESISTANCE) WITH GANCICLOVIR, VALGANCICLOVIR, CIDOFOVIR OR FOSCARNET |
| ODE-389 |
TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IMMUNOGLOBULIN A NEPHROPATHY (IGAN) AT RISK OF RAPID DISEASE PROGRESSION, GENERALLY A URINE PROTEIN-TO-CREATININE RATIO (UPCR) > OR = 1.5 G/G |
| 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-390 |
AS AN ADJUNCT FOR INTRAOPERATIVE IDENTIFICATION OF MALIGNANT LESIONS IN ADULT PATIENTS WITH OVARIAN CANCER |
| ODE-391 |
TREATMENT OF FACIAL ANGIOFIBROMA ASSOCIATED WITH TUBEROUS SCLEROSIS IN ADULTS AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER |
| ODE-392 |
TREATMENT OF HEMOLYTIC ANEMIA IN ADULTS WITH PYRUVATE KINASE (PK) DEFICIENCY |
| ODE-393 |
TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| ODE-394 |
FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE |
| ODE-395 |
TREATMENT OF SEIZURES ASSOCIATED WITH CYCLIN-DEPENDENT KINASE-LIKE 5 (CDKL5) DEFICIENCY DISORDER (CDD) IN PATIENTS 2 YEARS OF AGE AND OLDER |
| ODE-396 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY |
| ODE-397 |
TREATMENT OF ADULTS WITH INTERMEDIATE OR HIGH-RISK PRIMARY OR SECONDARY (POST-POLYCYTHEMIA VERA OR POST-ESSENTIAL THROMBOCYTHEMIA) MYELOFIBROSIS (MF) WITH A PLATELET COUNT BELOW 50 X 10^9/L |
| ODE-398 |
TREATMENT OF ADULTS WITH SYMPTOMATIC NEW YORK HEART ASSOCIATION (NYHA) CLASS II-III OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY (HCM) TO IMPROVE FUNCTIONAL CAPACITY AND SYMPTOMS |
| ODE-399 |
TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) |
| 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-400 |
TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PEDIATRIC PATIENTS BETWEEN BIRTH AND 2 MONTHS OF AGE |
| ODE-401 |
TREATMENT OF ADULT PATIENTS WITH STABLE WILSON’S DISEASE WHO ARE DE-COPPERED AND TOLERANT TO PENICILLAMINE |
| ODE-402 |
FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH MONOGENIC OR SYNDROMIC OBESITY DUE TO BARDET-BIEDL SYNDROME (BBS) |
| ODE-403 |
TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS TAKING CLOBAZAM WHO ARE 6 MONTHS TO LESS THAN 2 YEARS OF AGE AND WEIGHING 7 KG OR MORE |
| ODE-404 |
TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT |
| ODE-405 |
TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY |
| ODE-406 |
TO IMPROVE KIDNEY FUNCTION IN ADULTS WITH HEPATORENAL SYNDROME WITH RAPID REDUCTION IN KIDNEY FUNCTION |
| ODE-407 |
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE |
| ODE-408 |
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 1 YEAR TO LESS THAN 2 YEARS WHO ARE HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE |
| ODE-409 |
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS WITH A RET GENE FUSION THAT HAVE PROGRESSED ON OR FOLLOWING PRIOR SYSTEMIC TREATMENT OR WHO HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS |
| 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-410 |
TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC INTRAHEPATIC CHOLANGIOCARCINOMA HARBORING FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) GENE FUSIONS OR OTHER REARRANGEMENTS |
| ODE-411 |
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS |
| ODE-412 |
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) WITH A REARRANGED DURING TRANSFECTION (RET) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-413 |
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-414 |
TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS |
| ODE-415 |
TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) TO LOWER PLASMA OXALATE LEVELS IN PEDIATRIC AND ADULT PATIENTS |
| ODE-416 |
TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS |
| ODE-417 |
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011 |
| ODE-418 |
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES |
| ODE-419 |
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS |
| 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-420 |
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES |
| ODE-421 |
TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS |
| ODE-422 |
TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY |
| ODE-423 |
FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) |
| ODE-424 |
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR |
| ODE-425 |
TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| ODE-426 |
FOR USE IN PATIENTS 18 YEARS OF AGE OR OLDER WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS FOR THE TREATMENT OF CANDIDEMIA AND INVASIVE CANDIDIASIS |
| ODE-427 |
TREATMENT OF FRIEDREICH'S ATAXIA IN ADULTS AND ADOLESCENTS AGED 16 YEARS AND OLDER |
| ODE-428 |
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY |
| ODE-429 |
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 1 YEAR OF AGE WITH ALAGILLE SYNDROME (ALGS) |
| 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-430 |
TREATMENT OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA (PI3K DELTA) SYNDROME (APDS) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| ODE-431 |
TREATMENT OF CATAPLEXY OR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULTS WITH NARCOLEPSY |
| ODE-432 |
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE |
| ODE-433 |
TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR (CFTR) GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA |
| ODE-434 |
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM) |
| ODE-435 |
THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 1 MONTH TO LESS THAN 4 MONTHS OF AGE WHO HAVE AT LEAST ONE MUTATION IN THE CFTR GENE THAT IS RESPONSIVE TO IVACAFTOR POTENTIATION BASED ON CLINICAL AND/OR IN VITRO ASSAY DATA |
| ODE-436 |
TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 12 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) |
| ODE-437 |
FOR USE IN COMBINATION WITH STANDARD INDUCTION AND CONSOLIDATION, AND AS MAINTENANCE THERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 INTERNAL TANDEM DUPLICATION (ITD)-POSITIVE AS DETECTED BY AN FDA-APPROVED TEST |
| ODE-438 |
AS A LIVER-DIRECTED TREATMENT FOR ADULT PATIENTS WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES AFFECTING LESS THAN 50% OF THE LIVER AND NO EXTRAHEPATIC DISEASE OR EXTRAHEPATIC DISEASE LIMITED TO THE BONE, LYMPH NODES, SUBCUTANEOUS TISSUES, OR LUNG THAT IS AMENABLE TO RESECTION OR RADIATION |
| ODE-439 |
FOR THE REDUCTION IN VOLUME OF NEW HETEROTOPIC OSSIFICATION IN ADULTS AND PEDIATRIC PATIENTS AGED 8 YEARS AND OLDER FOR FEMALES AND 10 YEARS AND OLDER FOR MALES WITH FIBRODYSPLASIA OSSIFICANS PROGRESSIVA (FOP) |
| 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 |
