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New Drug Application (NDA) Efficacy Supplements Calendar Year Approvals: 2009

As of December 31, 2009

 

Selection Criteria:

User Response: Start Date: 1/1/2009 12:00:00 AM    End Date: 12/31/2009 

Sort Order: Approval Date

Established NameApplicantApplication NumberSupplement Type / Submission Class CodeSupplement NumberPriority ReviewGoal Init DateApproval DateTotal Approval Time (Months)Indication/Description
LIDOCAINE HCL MONOHYDRATE POWDER INTRADLANESIVA INCNDA 022114PAT POPUL1S3/10/20081/8/200910.0PROVIDES FOR THE USE ON INTACT SKIN TO PROVIDE TOPICAL LOCAL ANALGESIA PRIOR TO VENIPUNCTURE IN ADULTS.
RALTEGRAVIR POTASSIUMMERCK SHARP AND DOHME CORPNDA 022145ACCEL APP1S3/31/20081/29/200910.0PROVIDES FOR THE UPDATE OF THE PACKAGE INSERT AND PATIENT PACKAGE INSERT WITH THE 48 WEEK DATA FROM STUDIES TO SUPPORT USE OF THIS DRUG FOR THE TRATMENT OF HIV-1 INFECTION, IN COMBINATION WITH OTHER ANTIRETOVIRAL AGENTS, IN TREATMENT-EXPERIENCED ADULT PAT
LAMIVUDINE/ ZIDOVUDINEVIIV HEALTHCARE CONDA 020857PAT POPUL23P6/13/20082/2/20097.7PROVIDES FOR THE TREATMENT OF HIV-1 INFECTION, IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IN PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 30 KILOGRAMS.
BUDESONIDE/ FORMOTEROLASTRAZENECA LPNDA 021929INDICATION12S4/29/20082/27/200910.0PROVIDES FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD).
GLATIRAMER ACETATETEVA NEUROSCIENCE INCNDA 020622PAT POPUL57S5/1/20082/27/20099.9PROVIDES FOR THE USE FOR REDUCTION OF THE FREQUENCY OF RELAPSES IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS (RRMS), INCLUDING PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL EPISODE AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS.
SOMATROPIN, BIOSYNTHETICELI LILLY AND CONDA 019640INDICATION68S1/18/20083/12/200913.8PROVIDES FOR THE TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO NOT MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
ZOLEDRONIC ACID INJECTION 5MGNOVARTIS PHARMACEUTICALS CORPNDA 021817INDICATION3S2/15/20083/13/200912.9PROVIDES FOR THE INDICATION OF THE TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS EXPECTED TO BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS.
ESCITALOPRAM OXALATE 5/10/20MG TABLETSFOREST LABORATORIES INCNDA 021323PAT POPUL30S5/23/20083/19/20099.9PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD).
ESCITALOPRAM OXALATE 5/10/20MG TABLETSFOREST LABORATORIES INCNDA 021323PAT POPUL31S6/13/20083/19/20099.2PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD).
ESCITALOPRAM OXALATEFOREST LABORATORIES INCNDA 021365PAT POPUL21S5/23/20083/19/20099.9PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD).
ESCITALOPRAM OXALATEFOREST LABORATORIES INCNDA 021365PAT POPUL22S6/13/20083/19/20099.2PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD).
TIGECYCLINEWYETH PHARMACEUTICALS INCNDA 021821INDICATION13S7/27/20073/20/200919.8PROVIDES INFORMATION FOR THE INDICATION OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA.
TIGECYCLINEWYETH PHARMACEUTICALS INCNDA 021821INDICATION17S7/27/20073/20/200919.8PROVIDES INFORMATION FOR THE ADDITION OF PATHOGENS TO THE COMPLICATED SKIN AND SKIN STRUCTURE INDICATION
TIGECYCLINEWYETH PHARMACEUTICALS INCNDA 021821INDICATION18S7/27/20073/20/200919.8PROVIDES INFORMATION FOR THE ADDITION OF PATHOGENS TO THE COMPLICATED INTRA-ABDOMINAL INDICATION.
ANASTROZOLEASTRAZENECA UK LTDNDA 020541ACCEL APP24S7/1/20084/30/200910.0PROVIDES FOR THE FINAL STUDY REPORTS (12 MONTH AND 24 MONTH DATA) OF A DOUBLE BLIND, RANDOMIZED COMPARISON OF THE DRUG IN EARLY BREAST CANCER PATIENTS.  RESULTS OF THE HYPERLIPIDEMIA SUBSTUDY WAS CONTAINED IN THE 12 MONTH STUDY.
HYDROMORPHONE HYDROCHLORIDEPURDUE PHARMACEUTICAL PRODUCTS LPNDA 019034DOSING18S9/4/20074/30/200919.9PROVIDES FOR ADDITIONAL STRENGTHS OF DILAUDID INJECTION FOR THE MANAGEMENT OF PAIN IN PATIENTS WHERE AN OPIOID ANALGESIC IS APPROPRIATE.
ALMOTRIPTAN MALATEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 021001PAT POPUL11P10/31/20084/30/20096.0PROVIDES FOR THE ACUTE TREATMENT OF PEDIATRIC MIGRAINE.
SILDENAFIL CITRATEPFIZER INCNDA 021845INDICATION6S11/7/20085/7/20096.0PROVIDES FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING.
AMLODIPINE BESYLATE/ OLMESARTAN MEDOXOMILDAIICHI SANKYO INCNDA 022100INDICATION2S7/11/20085/11/200910.0PROVIDES FOR THE USE AS INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE ANTIHYPERTENSIVE AGENTS TO ACHIEVE THEIR BLOOD PRESSURE GOALS.
RISPERIDONEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 021346INDICATION25S4/9/20085/15/200913.2PROVIDES FOR THE USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER.
RISPERIDONEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 021346INDICATION28S7/21/20085/15/20099.8PROVIDES FOR THE MAINTENANCE OF BIPOLAR I DISORDER.
DASATINIB 20/50/70MG TABLETSBRISTOL MYERS SQUIBB CONDA 021986DOSING4S8/4/20085/21/20099.5PROVIDES FOR THE TREATMENT OF ADULTS WITH CHRONIC , ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE CHRONIC MYELOID LEUKEMIA WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB AND THE TREATMENT OF ADULTS WITH PHILADELPHIA CHROMOSOME-POSITI
TADALAFILELI LILLY CONDA 022332TYPE 61S7/24/20085/22/20099.9PROVIDES FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO IMPROVE EXERCISE ABILITY.
IMATINIB MESYLATE TABLETSNOVARTIS PHARMACEUTICALS CORPNDA 021588ACCEL APP26S8/1/20085/27/20099.8PROVIDES FOR THE TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA  IN THE CHRONIC PHASE.
ZOLEDRONIC ACID INJECTION 5MGNOVARTIS PHARMACEUTICALS CORPNDA 021817INDICATION4S7/30/20085/29/200910.0PROVIDES FOR THE PREVENTION OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN.
RIFAPENTINESANOFI AVENTIS US LLCNDA 021024ACCEL APP8S7/13/20076/1/200922.7PROVIDES DRAFT LABELING FOR THE PACKAGE INSERT.
PARICALCITO CAPSULESABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVNDA 021606INDICATION4S5/12/20066/29/200937.6PROVIDES FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS.
PEMETREXED DISODIUMELI LILLY AND CONDA 021462ACCEL APP21S9/16/20087/2/20099.5PROVIDES FOR INTRAVENOUS USE 100 MG AND 500 MG VIALS IN 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.
RALTEGRAVIR POTASSIUMMERCK SHARP AND DOHME CORPNDA 022145PAT POPUL4S9/26/20087/8/20099.4PROVIDES FOR THE USE IN COMBINATION WITH OTHER ANTIRETROVIRALS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAÏVE ADULT PATIENTS.
LEVONORGESTRELDURAMED PHARMACEUTICALS INCNDA 021045PAT POPUL15S6/12/20097/10/20090.9PROVIDES FOR OVER-THE-COUNTER (OTC) AVAILABILITY FOR WOMEN AGE 17 YEARS AND PRESCRIPTION AVAILABILITY FOR WOMEN YOUNGER THAN AGE 17 YEARS
ALISKIREN HYDROCHLOROTHIAZIDENOVARTIS PHARMACEUTICALS CORPNDA 022107INDICATION2S9/30/20087/16/20099.5PROVIDES FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS.
TERIPARATIDE (DNA ORIGIN)INJELI LILLY AND CONDA 021318INDICATION12S2/12/20077/22/200929.3PROVIDES FOR THE TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE.
PALIPERIDONEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 021999INDICATION13S2/4/20097/31/20095.8PROVIDE FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS.
PALIPERIDONEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 021999INDICATION14S2/4/20097/31/20095.8PROVIDE FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS.
BOSENTAN 62.5MG/125MG TABLETSACTELION LTDNDA 021290INDICATION12S8/6/20078/7/200924.1PROVIDES FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP I) IN PATIENTS WITH WHO CLASS II TO IV SYMPTOMS TO IMPROVE EXERCISE CAPACITY AND DECREASE CLINICAL WORSENING.
LEVOCETIRIZINE DIHYDROCHLORIDEUCB INCNDA 022064PAT POPUL17P2/25/20098/21/20095.8PROVIDES FOR RELIEF OF SYMPTOMS ASSOCIATED WITH SAR, PAR, AND CIU
LEVOCETIRZINE DIHYDROCHLORIDEUCB INCNDA 022157PAT POPUL3P2/25/20098/21/20095.8PROVIDES FOR RELIEF OF SYMPTOMS ASSOCIATED WITH SAR, PAR, AND CIU
AZELASTINE HYDROCHLORIDE NASAL SPRAYMEDA PHARMACEUTICALS INCNDA 022371TYPE 61S8/1/20088/31/200913.0PROVIDES FOR THE RELIEF OF SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
LEZONORGESTREL RELEASING INTRA-UTERINE SBAYER HEALTHCARE PHARMACEUTICALS INCNDA 021225INDICATION27P4/1/200910/1/20096.0PROVIDES FOR THE TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
COLESEVELAM HYDROCHLORIDEDAIICHI SANKYO INCNDA 021176PAT POPUL22P12/10/200810/2/20099.7PROVIDES TO REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS 10-17 YEARS OF AGE, WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
ROSUVASTATIN CALCIUM TABLETSIPR PHARMACEUTICALS INCNDA 021366PAT POPUL17P4/16/200910/15/20096.0PROVIDES FOR THE ADDITION OF AN INDICATION FOR THE TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDED DOSING RANGE OF 5 TO 20 MG ONCE DAILY
TELMISARTAN 40MG/80MG TABSBOEHRINGER INGELHEIMNDA 020850INDICATION25S12/16/200810/16/200910.0PROVIDES 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.
HYDROCORTISONE BUTYRATETRIAX PHARMACEUTICALS LLCNDA 020769PAT POPUL11S12/19/200810/19/200910.0PROVIDES FOR TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18 YEARS OF AGE
CANDESARTAN CILEXETILASTRAZENECA PHARMACEUTICALS LPNDA 020838PAT POPUL31P4/23/200910/22/20096.0PROVIDES FOR TREATMENT OF HYPERTENSION IN CHILDREN 1 TO <17 YEARS OF AGE
DEXMETHYLPHENIDATE ER CAPSULESNOVARTIS PHARMACEUTICALS CORPNDA 021802DOSING14S3/31/200910/23/20096.8PROVIDES FOR THE REMOVAL THE 20 MG MAXIMUM DOSE RESTRICTION FROM FOCALIN XR LABELING.
AVOBENZENE/ ECAMSULE/ OCTOCRYLENE/ TITANIUMLOREAL USA PRODUCTS INCNDA 022009MANU W CLIN2S9/18/200810/29/200913.3PROVIDES FOR THE PREVENTION OF SUNBURN, HIGHER SPF GIVES MORE SUNBURN PROTECTION, HELPS PROVIDE PROTECTION FROM UVA RAYS (SHORT AND LONG WAVELENGTHS)
EXENATIDEAMYLIN PHARMACEUTICALS INCNDA 021919TYPE 61S6/30/200410/30/200964.0PROVIDES FOR THE IMPROVEMENT OF GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AS MONOTHERAPY
ZIDOVUDINEGLAXO GROUP LTD DBA GLAXOSMITHKLINENDA 019910PAT POPUL35P5/7/200911/6/20096.0PROVIDES DOSING RECOMMENDATIONS FOR PATIENTS AGED 4 WEEKS TO LESS THAN 6 WEEKS AND WEIGHING AT LEAST 4 KG FOR THE TREATMENT OF HIV-1 INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS.
PANTOPRAZOLE SODIUMWYETH PHARMACEUTICALS INCNDA 020987PAT POPUL36S5/12/200911/12/20096.0PROVIDES FOR SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS AGES FIVE YEARS AND OLDER
ARIPIPRAZOLEOTSUKA PHARMACEUTICAL CO LTDNDA 021436INDICATION27S1/21/200911/19/20099.9PROVIDES FOR THE TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS (AGED 6 TO 17 YEARS).
DULOXETINE HCLELI LILLY AND CONDA 021427INDICATION30S2/2/200911/19/20099.5PROVIDES FOR THE MAINTENANCE OF GENERALIZED ANXIETY DISORDER
ZIPRASIDONE HCLPFIZER INCNDA 020825INDICATION34S12/19/200811/20/200911.0PROVIDES FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
MARAVIROC UK-427,857PFIZER LABORATORIES DIV PFIZER INCNDA 022128PAT POPUL2S12/23/200811/20/200910.9PROVIDES FOR THE EXPANSION OF THE INDICATION TO TREATMENT OF THERAPY-NAIVE ADULTS INFECTED WITH CCR5-TROPIC HIV-1 IN COMINBATION WITH OTHER ANTIRETROVIRAL AGENTS.
TMC 125 ETRAVIRINETIBOTEC INCNDA 022187ACCEL APP1S1/30/200911/24/20099.8PROVIDES FOR THE USE IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL AGENT
17-B-ESTRADIOLNOVO NORDISK INCNDA 020908DOSING13S5/26/200911/25/20096.0PROVIDES FOR THE USE OF VAGIFEM (ESTRADIOL VAGINAL TABLETS) 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
OLOPATADINE HCL 0.6%ALCON INCNDA 021861PAT POPUL2P6/1/200912/1/20096.0RELIEF OF NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADOLESCENTS, ADULTS, AND CHILDREN 6 YEARS OF AGE AND ABOVE
QUETIAPINE FUMARATEASTRAZENECA LPNDA 020639PAT POPUL45P10/28/200812/2/200913.2TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS 13 TO 17 YEARS OF AGE AND THE TREATMENT OF BIPOLAR MANIA IN CHILDREN AND ADOLESCENTS 10 TO 17 YEARS OF AGE
QUETIAPINE FUMARATEASTRAZENECA LPNDA 020639PAT POPUL46P10/28/200812/2/200913.2TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS 13 TO 17 YEARS OF AGE AND THE TREATMENT OF BIPOLAR MANIA IN CHILDREN AND ADOLESCENTS 10 TO 17 YEARS OF AGE
QUETIAPINE FUMARATEASTRAZENECA PHARMACEUTICALS LPNDA 022047INDICATION11S2/27/200812/2/200921.2ADJUNCTIVE THERAPY FOR TREATMENT OF MAJOR DEPRESSIVE DISORDER
OLANZAPINEELI LILLY AND CONDA 020592PAT POPUL40P10/31/200612/4/200937.2TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER AND SCHIZOPHRENIA IN ADOLESCENTS
OLANZAPINEELI LILLY AND CONDA 020592PAT POPUL41P10/31/200612/4/200937.2TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER AND SCHIZOPHRENIA IN ADOLESCENTS
TOPIRAMATEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 020505PAT POPUL37P4/25/200812/22/200919.9ADDS CLINICAL TRIAL DATA TO THE PEDIATRIC USE SUBSECTION OF THE USE IN SPECIFIC POPULATIONS SECTION
TOPIRAMATEORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA 020844PAT POPUL31P4/25/200812/22/200919.9ADDS CLINICAL TRIAL DATA TO THE PEDIATRIC USE SUBSECTION OF THE USE IN SPECIFIC POPULATIONS SECTION

 

 

NDA Efficacy Supplements Approved (SE8)

Established NameApplicantApplication NumberSupplement Type / Submission Class CodeSupplement NumberPriority ReviewGoal Init DateApproval DateTotal Approval Time (Months)
TELBIVUDINENOVARTIS PHARMACEUTICALS CORPNDA 022011LABEL W CLIN1S12/24/20071/23/200913.0
FLUOXETINE HYDROCHLORIDELILLY RESEARCH LABORATORIES DIV ELI LILLY AND CONDA 018936LABEL W CLIN77P9/29/20063/19/200929.7
OLANZAPINEELI LILLY AND CONDA 020592LABEL W CLIN39P9/29/20063/19/200929.7
OLANZAPINEELI LILLY AND CONDA 021086LABEL W CLIN21P9/29/20063/19/200929.7
OLANZAPINE; FLUOXETINE HYDROCHLORIDEELI LILLY AND CONDA 021520LABEL W CLIN12P9/29/20063/19/200929.7
SALMETEROL/FLUTICASONE PROPIONATE INHALAGLAXOSMITHKLINENDA 021077LABEL W CLIN36S9/19/20083/31/20096.3
LOPINAVIR; RITONAVIRABBOTT LABORATORIESNDA 021251LABEL W CLIN26S6/25/20084/20/20099.8
LOPINAVIR; RITONAVIRABBOTT LABORATORIESNDA 021906LABEL W CLIN17S6/25/20084/20/20099.8
NICOTINE POLACRILEXGLAXOSMITHKLINENDA 018612LABEL W CLIN52S7/8/20085/6/20099.9
NICOTINE POLACRILEXGLAXOSMITHKLINENDA 020066LABEL W CLIN33S7/8/20085/6/20099.9
 ASTELLAS PHARMA US INCNDA 050708LABEL W CLIN27S2/14/20065/19/200939.1
 ASTELLAS PHARMA US INCNDA 050709LABEL W CLIN21P2/14/20065/19/200939.1
LISDEXAMFETAMINE DIMESYLATESHIRE DEVELOPMENT INCNDA 021977LABEL W CLIN7S7/31/20085/22/20099.7
OLOPATADINE HCL 0.6%ALCON INCNDA 021861LABEL W CLIN1S8/19/20086/17/20099.9
ESOMEPRAZOLE MAGNESIUM 20/40MGASTRAZENECA LPNDA 021957LABEL W CLIN5S12/18/20086/18/20096.0
CASPOFUNGIN ACETATEMERCK AND CO INCNDA 021227LABEL W CLIN23S9/5/20086/26/20099.7
ENTECAVIR TABLETS 0.5/1MGBRISTOL MYERS SQUIBBNDA 021797LABEL W CLIN8S9/26/20087/16/20099.6
ENTECAVIR ORAL SOLUTION 0.05MG/MLBRISTOL MYERS SQUIBBNDA 021798LABEL W CLIN8S9/26/20087/16/20099.6
RISEDRONATE SODIUMPROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CONDA 020835LABEL W CLIN35P1/26/20097/23/20095.9
INSULIN GLARGINESANOFI AVENTIS US LLCNDA 021081LABEL W CLIN34S12/21/20079/9/200920.6
OMEGA-3-ACID ETHYL ESTERSSMITHKLINE BEECHAMNDA 021654LABEL W CLIN22S9/5/20089/16/200912.4
VORINOSTATMERCK AND CO INCNDA 021991LABEL W CLIN4S2/10/20099/23/20097.4
 ASPIRIN; DIPYRIDAMOLEBOEHRINGER INGELHEIM PHARMACEUTICALS INCNDA 020884LABEL W CLIN18S12/2/200810/1/200910.0
IXABEPILONEBRISTOL MYERS SQUIBB CONDA 022065LABEL W CLIN2S12/12/200810/2/20099.7
TENOFOVIR DISOPROXIL FUMARATEGILEAD SCIENCES INCNDA 021356LABEL W CLIN27S12/8/200810/7/200910.0
(DIVALPROEX SODIUM)EXTENDED RELEASE TABSABBOTT LABORATORIESNDA 022267LABEL W CLIN1S12/16/200810/15/200910.0
METHYLPHENIDATE HYDROCHLORIDEORTHO MCNEIL JANSSEN PHARMACEUTICAL INCNDA 021121LABEL W CLIN22S12/23/200811/4/200910.4
ATAZANAVIR SULFATEBRISTOL MYERS SQUIBB CONDA 021567LABEL W CLIN19S1/5/200911/5/200910.0
RASAGILINE MESYLATETEVA NEUROSCIENCE INCNDA 021641LABEL W CLIN8S2/9/200912/9/200910.0
TIOTROPIUM BROMIDEBOEHRINGER INGELHEIM PHARMACEUTICALS INCNDA 021395LABEL W CLIN29S11/18/200812/17/200913.0
TAMSULOSIN HCLBOEHRINGER INGELHEIM PHARMACEUTICALS INCNDA 020579LABEL W CLIN26P6/26/200912/22/20095.9
FAMCICLOVIRNOVARTIS PHARMACEUTICALS CORPNDA 020363LABEL W CLIN36P6/30/200912/24/20095.8
BORTEZOMIBMILLENNIUM PHARMACEUTICALS INCNDA 021602LABEL W CLIN19S7/1/200912/30/20096.0
BORTEZOMIBMILLENNIUM PHARMACEUTICALS INCNDA 021602LABEL W CLIN20P7/2/200912/30/20096.0

 

BLA Efficacy Supplements Approved

PROPER NAMEAPPLICANTBLA NUMBERSUPPLEMENT NUMBERPRIORITY REVIEWRECEIPT DATEAPPROVAL DATETOTAL APPROVAL TIME (IN MONTHS)INDICATION
OPRELVEKINWYETH PHARMACEUTICALS INC.L 1036941008S108/27/19992/13/2009113.7REVISE THE CLINICAL PHARMACOLOGY: PHARMACOKINETICS SUBSECTION OF THE PACKAGE INSERT AND TO INCLUDE A GERIATRIC USE SUBSECTION
PEGINTERFERON ALFA-2BSCHERING CORPORATIONL 1039495125S108/1/20063/10/200931.3TO EXPAND THE INDICATION TO INCLUDE THE RETREATMENT OF CHRONIC HEPATITIS C SUBJECTS WHO HAVE FAIL OR RELAPSE AFTER PREVIOUS TREATMENT WITH COMBINATION ALPHA INTERFERON/RIBAVIRIN THERAPY
ABOBOTULINUMTOXINAIPSEN BIOPHARM LIMITEDL 1252741S103/14/20084/29/200913.5FORMERLY BLA 125286/0 -- (CONVERTED TO EFFICACY SUPPLEMENT UNDER THIS BLA) FOR TEMPORARY IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE GLABELLAR LINES
BEVACIZUMABGENENTECH, INC.L 125085169P0611/3/20085/5/20096.0INCLUDE A NEW INDICATION FOR BEVACIZUMAB FOR THE TREATMENT OF PATIENTS WITH GLIOBLASTOMA WITH PROGRESSIVE DISEASE FOLLOWING PRIOR THERAPY.
PEGINTERFERON ALFA-2BSCHERING CORPORATIONL 1039495172S107/8/20085/8/200910.0TO UPDATE THE PI WITH THE RESULTS OF THE IDEAL STUDY, P03471; EXPANDING THE INDICATION TO INCLUDE PATIENTS WITH HISTOLOGIC EVIDENCE OF CIRRHOSIS AND NORMAL AND ABNORMAL ALT LEVESL, A TWO-STEP DOSE REDUCTION SCHEME AND WEIGHT-BASED DOSING OF REBETOL FOR PA
CERTOLIZUMAB PEGOLUCB, INC.L 12516080S1012/6/20075/13/200917.2NEW INDICATION FOR TREATMENT OF RHEUMATOID ARTHRITIS -- ORIGINALLY FILED AS STN 125271/0
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