Drugs
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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 Name | Applicant | Application Number | Supplement Type / Submission Class Code | Supplement Number | Priority Review | Goal Init Date | Approval Date | Total Approval Time (Months) | Indication/Description |
|---|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HCL MONOHYDRATE POWDER INTRADL | ANESIVA INC | NDA 022114 | PAT POPUL | 1 | S | 3/10/2008 | 1/8/2009 | 10.0 | PROVIDES FOR THE USE ON INTACT SKIN TO PROVIDE TOPICAL LOCAL ANALGESIA PRIOR TO VENIPUNCTURE IN ADULTS. |
| RALTEGRAVIR POTASSIUM | MERCK SHARP AND DOHME CORP | NDA 022145 | ACCEL APP | 1 | S | 3/31/2008 | 1/29/2009 | 10.0 | PROVIDES 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/ ZIDOVUDINE | VIIV HEALTHCARE CO | NDA 020857 | PAT POPUL | 23 | P | 6/13/2008 | 2/2/2009 | 7.7 | PROVIDES FOR THE TREATMENT OF HIV-1 INFECTION, IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IN PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 30 KILOGRAMS. |
| BUDESONIDE/ FORMOTEROL | ASTRAZENECA LP | NDA 021929 | INDICATION | 12 | S | 4/29/2008 | 2/27/2009 | 10.0 | PROVIDES FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). |
| GLATIRAMER ACETATE | TEVA NEUROSCIENCE INC | NDA 020622 | PAT POPUL | 57 | S | 5/1/2008 | 2/27/2009 | 9.9 | PROVIDES 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, BIOSYNTHETIC | ELI LILLY AND CO | NDA 019640 | INDICATION | 68 | S | 1/18/2008 | 3/12/2009 | 13.8 | PROVIDES 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 5MG | NOVARTIS PHARMACEUTICALS CORP | NDA 021817 | INDICATION | 3 | S | 2/15/2008 | 3/13/2009 | 12.9 | PROVIDES 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 TABLETS | FOREST LABORATORIES INC | NDA 021323 | PAT POPUL | 30 | S | 5/23/2008 | 3/19/2009 | 9.9 | PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD). |
| ESCITALOPRAM OXALATE 5/10/20MG TABLETS | FOREST LABORATORIES INC | NDA 021323 | PAT POPUL | 31 | S | 6/13/2008 | 3/19/2009 | 9.2 | PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD). |
| ESCITALOPRAM OXALATE | FOREST LABORATORIES INC | NDA 021365 | PAT POPUL | 21 | S | 5/23/2008 | 3/19/2009 | 9.9 | PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD). |
| ESCITALOPRAM OXALATE | FOREST LABORATORIES INC | NDA 021365 | PAT POPUL | 22 | S | 6/13/2008 | 3/19/2009 | 9.2 | PROVIDES FOR THE ACUTE AND MAINTENANCE TREATMENT OF ADOLESCENT MAJOR DEPRESSIVE DISORDER (MDD). |
| TIGECYCLINE | WYETH PHARMACEUTICALS INC | NDA 021821 | INDICATION | 13 | S | 7/27/2007 | 3/20/2009 | 19.8 | PROVIDES INFORMATION FOR THE INDICATION OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA. |
| TIGECYCLINE | WYETH PHARMACEUTICALS INC | NDA 021821 | INDICATION | 17 | S | 7/27/2007 | 3/20/2009 | 19.8 | PROVIDES INFORMATION FOR THE ADDITION OF PATHOGENS TO THE COMPLICATED SKIN AND SKIN STRUCTURE INDICATION |
| TIGECYCLINE | WYETH PHARMACEUTICALS INC | NDA 021821 | INDICATION | 18 | S | 7/27/2007 | 3/20/2009 | 19.8 | PROVIDES INFORMATION FOR THE ADDITION OF PATHOGENS TO THE COMPLICATED INTRA-ABDOMINAL INDICATION. |
| ANASTROZOLE | ASTRAZENECA UK LTD | NDA 020541 | ACCEL APP | 24 | S | 7/1/2008 | 4/30/2009 | 10.0 | PROVIDES 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 HYDROCHLORIDE | PURDUE PHARMACEUTICAL PRODUCTS LP | NDA 019034 | DOSING | 18 | S | 9/4/2007 | 4/30/2009 | 19.9 | PROVIDES FOR ADDITIONAL STRENGTHS OF DILAUDID INJECTION FOR THE MANAGEMENT OF PAIN IN PATIENTS WHERE AN OPIOID ANALGESIC IS APPROPRIATE. |
| ALMOTRIPTAN MALATE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 021001 | PAT POPUL | 11 | P | 10/31/2008 | 4/30/2009 | 6.0 | PROVIDES FOR THE ACUTE TREATMENT OF PEDIATRIC MIGRAINE. |
| SILDENAFIL CITRATE | PFIZER INC | NDA 021845 | INDICATION | 6 | S | 11/7/2008 | 5/7/2009 | 6.0 | PROVIDES FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING. |
| AMLODIPINE BESYLATE/ OLMESARTAN MEDOXOMIL | DAIICHI SANKYO INC | NDA 022100 | INDICATION | 2 | S | 7/11/2008 | 5/11/2009 | 10.0 | PROVIDES FOR THE USE AS INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE ANTIHYPERTENSIVE AGENTS TO ACHIEVE THEIR BLOOD PRESSURE GOALS. |
| RISPERIDONE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 021346 | INDICATION | 25 | S | 4/9/2008 | 5/15/2009 | 13.2 | PROVIDES FOR THE USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER. |
| RISPERIDONE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 021346 | INDICATION | 28 | S | 7/21/2008 | 5/15/2009 | 9.8 | PROVIDES FOR THE MAINTENANCE OF BIPOLAR I DISORDER. |
| DASATINIB 20/50/70MG TABLETS | BRISTOL MYERS SQUIBB CO | NDA 021986 | DOSING | 4 | S | 8/4/2008 | 5/21/2009 | 9.5 | PROVIDES 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 |
| TADALAFIL | ELI LILLY CO | NDA 022332 | TYPE 6 | 1 | S | 7/24/2008 | 5/22/2009 | 9.9 | PROVIDES FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION TO IMPROVE EXERCISE ABILITY. |
| IMATINIB MESYLATE TABLETS | NOVARTIS PHARMACEUTICALS CORP | NDA 021588 | ACCEL APP | 26 | S | 8/1/2008 | 5/27/2009 | 9.8 | PROVIDES FOR THE TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA IN THE CHRONIC PHASE. |
| ZOLEDRONIC ACID INJECTION 5MG | NOVARTIS PHARMACEUTICALS CORP | NDA 021817 | INDICATION | 4 | S | 7/30/2008 | 5/29/2009 | 10.0 | PROVIDES FOR THE PREVENTION OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN. |
| RIFAPENTINE | SANOFI AVENTIS US LLC | NDA 021024 | ACCEL APP | 8 | S | 7/13/2007 | 6/1/2009 | 22.7 | PROVIDES DRAFT LABELING FOR THE PACKAGE INSERT. |
| PARICALCITO CAPSULES | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | NDA 021606 | INDICATION | 4 | S | 5/12/2006 | 6/29/2009 | 37.6 | PROVIDES FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS. |
| PEMETREXED DISODIUM | ELI LILLY AND CO | NDA 021462 | ACCEL APP | 21 | S | 9/16/2008 | 7/2/2009 | 9.5 | PROVIDES 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 POTASSIUM | MERCK SHARP AND DOHME CORP | NDA 022145 | PAT POPUL | 4 | S | 9/26/2008 | 7/8/2009 | 9.4 | PROVIDES FOR THE USE IN COMBINATION WITH OTHER ANTIRETROVIRALS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAÏVE ADULT PATIENTS. |
| LEVONORGESTREL | DURAMED PHARMACEUTICALS INC | NDA 021045 | PAT POPUL | 15 | S | 6/12/2009 | 7/10/2009 | 0.9 | PROVIDES FOR OVER-THE-COUNTER (OTC) AVAILABILITY FOR WOMEN AGE 17 YEARS AND PRESCRIPTION AVAILABILITY FOR WOMEN YOUNGER THAN AGE 17 YEARS |
| ALISKIREN HYDROCHLOROTHIAZIDE | NOVARTIS PHARMACEUTICALS CORP | NDA 022107 | INDICATION | 2 | S | 9/30/2008 | 7/16/2009 | 9.5 | PROVIDES FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS. |
| TERIPARATIDE (DNA ORIGIN)INJ | ELI LILLY AND CO | NDA 021318 | INDICATION | 12 | S | 2/12/2007 | 7/22/2009 | 29.3 | PROVIDES FOR THE TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE. |
| PALIPERIDONE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 021999 | INDICATION | 13 | S | 2/4/2009 | 7/31/2009 | 5.8 | PROVIDE FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS. |
| PALIPERIDONE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 021999 | INDICATION | 14 | S | 2/4/2009 | 7/31/2009 | 5.8 | PROVIDE FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS. |
| BOSENTAN 62.5MG/125MG TABLETS | ACTELION LTD | NDA 021290 | INDICATION | 12 | S | 8/6/2007 | 8/7/2009 | 24.1 | PROVIDES 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 DIHYDROCHLORIDE | UCB INC | NDA 022064 | PAT POPUL | 17 | P | 2/25/2009 | 8/21/2009 | 5.8 | PROVIDES FOR RELIEF OF SYMPTOMS ASSOCIATED WITH SAR, PAR, AND CIU |
| LEVOCETIRZINE DIHYDROCHLORIDE | UCB INC | NDA 022157 | PAT POPUL | 3 | P | 2/25/2009 | 8/21/2009 | 5.8 | PROVIDES FOR RELIEF OF SYMPTOMS ASSOCIATED WITH SAR, PAR, AND CIU |
| AZELASTINE HYDROCHLORIDE NASAL SPRAY | MEDA PHARMACEUTICALS INC | NDA 022371 | TYPE 6 | 1 | S | 8/1/2008 | 8/31/2009 | 13.0 | PROVIDES 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 S | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 021225 | INDICATION | 27 | P | 4/1/2009 | 10/1/2009 | 6.0 | PROVIDES FOR THE TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION |
| COLESEVELAM HYDROCHLORIDE | DAIICHI SANKYO INC | NDA 021176 | PAT POPUL | 22 | P | 12/10/2008 | 10/2/2009 | 9.7 | PROVIDES 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 TABLETS | IPR PHARMACEUTICALS INC | NDA 021366 | PAT POPUL | 17 | P | 4/16/2009 | 10/15/2009 | 6.0 | PROVIDES 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 TABS | BOEHRINGER INGELHEIM | NDA 020850 | INDICATION | 25 | S | 12/16/2008 | 10/16/2009 | 10.0 | PROVIDES 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 BUTYRATE | TRIAX PHARMACEUTICALS LLC | NDA 020769 | PAT POPUL | 11 | S | 12/19/2008 | 10/19/2009 | 10.0 | PROVIDES FOR TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18 YEARS OF AGE |
| CANDESARTAN CILEXETIL | ASTRAZENECA PHARMACEUTICALS LP | NDA 020838 | PAT POPUL | 31 | P | 4/23/2009 | 10/22/2009 | 6.0 | PROVIDES FOR TREATMENT OF HYPERTENSION IN CHILDREN 1 TO <17 YEARS OF AGE |
| DEXMETHYLPHENIDATE ER CAPSULES | NOVARTIS PHARMACEUTICALS CORP | NDA 021802 | DOSING | 14 | S | 3/31/2009 | 10/23/2009 | 6.8 | PROVIDES FOR THE REMOVAL THE 20 MG MAXIMUM DOSE RESTRICTION FROM FOCALIN XR LABELING. |
| AVOBENZENE/ ECAMSULE/ OCTOCRYLENE/ TITANIUM | LOREAL USA PRODUCTS INC | NDA 022009 | MANU W CLIN | 2 | S | 9/18/2008 | 10/29/2009 | 13.3 | PROVIDES FOR THE PREVENTION OF SUNBURN, HIGHER SPF GIVES MORE SUNBURN PROTECTION, HELPS PROVIDE PROTECTION FROM UVA RAYS (SHORT AND LONG WAVELENGTHS) |
| EXENATIDE | AMYLIN PHARMACEUTICALS INC | NDA 021919 | TYPE 6 | 1 | S | 6/30/2004 | 10/30/2009 | 64.0 | PROVIDES FOR THE IMPROVEMENT OF GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AS MONOTHERAPY |
| ZIDOVUDINE | GLAXO GROUP LTD DBA GLAXOSMITHKLINE | NDA 019910 | PAT POPUL | 35 | P | 5/7/2009 | 11/6/2009 | 6.0 | PROVIDES 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 SODIUM | WYETH PHARMACEUTICALS INC | NDA 020987 | PAT POPUL | 36 | S | 5/12/2009 | 11/12/2009 | 6.0 | PROVIDES FOR SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC PATIENTS AGES FIVE YEARS AND OLDER |
| ARIPIPRAZOLE | OTSUKA PHARMACEUTICAL CO LTD | NDA 021436 | INDICATION | 27 | S | 1/21/2009 | 11/19/2009 | 9.9 | PROVIDES FOR THE TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS (AGED 6 TO 17 YEARS). |
| DULOXETINE HCL | ELI LILLY AND CO | NDA 021427 | INDICATION | 30 | S | 2/2/2009 | 11/19/2009 | 9.5 | PROVIDES FOR THE MAINTENANCE OF GENERALIZED ANXIETY DISORDER |
| ZIPRASIDONE HCL | PFIZER INC | NDA 020825 | INDICATION | 34 | S | 12/19/2008 | 11/20/2009 | 11.0 | PROVIDES FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE |
| MARAVIROC UK-427,857 | PFIZER LABORATORIES DIV PFIZER INC | NDA 022128 | PAT POPUL | 2 | S | 12/23/2008 | 11/20/2009 | 10.9 | PROVIDES 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 ETRAVIRINE | TIBOTEC INC | NDA 022187 | ACCEL APP | 1 | S | 1/30/2009 | 11/24/2009 | 9.8 | PROVIDES 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-ESTRADIOL | NOVO NORDISK INC | NDA 020908 | DOSING | 13 | S | 5/26/2009 | 11/25/2009 | 6.0 | PROVIDES FOR THE USE OF VAGIFEM (ESTRADIOL VAGINAL TABLETS) 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE |
| OLOPATADINE HCL 0.6% | ALCON INC | NDA 021861 | PAT POPUL | 2 | P | 6/1/2009 | 12/1/2009 | 6.0 | RELIEF OF NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADOLESCENTS, ADULTS, AND CHILDREN 6 YEARS OF AGE AND ABOVE |
| QUETIAPINE FUMARATE | ASTRAZENECA LP | NDA 020639 | PAT POPUL | 45 | P | 10/28/2008 | 12/2/2009 | 13.2 | TREATMENT 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 FUMARATE | ASTRAZENECA LP | NDA 020639 | PAT POPUL | 46 | P | 10/28/2008 | 12/2/2009 | 13.2 | TREATMENT 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 FUMARATE | ASTRAZENECA PHARMACEUTICALS LP | NDA 022047 | INDICATION | 11 | S | 2/27/2008 | 12/2/2009 | 21.2 | ADJUNCTIVE THERAPY FOR TREATMENT OF MAJOR DEPRESSIVE DISORDER |
| OLANZAPINE | ELI LILLY AND CO | NDA 020592 | PAT POPUL | 40 | P | 10/31/2006 | 12/4/2009 | 37.2 | TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER AND SCHIZOPHRENIA IN ADOLESCENTS |
| OLANZAPINE | ELI LILLY AND CO | NDA 020592 | PAT POPUL | 41 | P | 10/31/2006 | 12/4/2009 | 37.2 | TREATMENT OF MANIC OR MIXED EPISODES OF BIPOLAR I DISORDER AND SCHIZOPHRENIA IN ADOLESCENTS |
| TOPIRAMATE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 020505 | PAT POPUL | 37 | P | 4/25/2008 | 12/22/2009 | 19.9 | ADDS CLINICAL TRIAL DATA TO THE PEDIATRIC USE SUBSECTION OF THE USE IN SPECIFIC POPULATIONS SECTION |
| TOPIRAMATE | ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC | NDA 020844 | PAT POPUL | 31 | P | 4/25/2008 | 12/22/2009 | 19.9 | ADDS CLINICAL TRIAL DATA TO THE PEDIATRIC USE SUBSECTION OF THE USE IN SPECIFIC POPULATIONS SECTION |
NDA Efficacy Supplements Approved (SE8)
| Established Name | Applicant | Application Number | Supplement Type / Submission Class Code | Supplement Number | Priority Review | Goal Init Date | Approval Date | Total Approval Time (Months) |
|---|---|---|---|---|---|---|---|---|
| TELBIVUDINE | NOVARTIS PHARMACEUTICALS CORP | NDA 022011 | LABEL W CLIN | 1 | S | 12/24/2007 | 1/23/2009 | 13.0 |
| FLUOXETINE HYDROCHLORIDE | LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO | NDA 018936 | LABEL W CLIN | 77 | P | 9/29/2006 | 3/19/2009 | 29.7 |
| OLANZAPINE | ELI LILLY AND CO | NDA 020592 | LABEL W CLIN | 39 | P | 9/29/2006 | 3/19/2009 | 29.7 |
| OLANZAPINE | ELI LILLY AND CO | NDA 021086 | LABEL W CLIN | 21 | P | 9/29/2006 | 3/19/2009 | 29.7 |
| OLANZAPINE; FLUOXETINE HYDROCHLORIDE | ELI LILLY AND CO | NDA 021520 | LABEL W CLIN | 12 | P | 9/29/2006 | 3/19/2009 | 29.7 |
| SALMETEROL/FLUTICASONE PROPIONATE INHALA | GLAXOSMITHKLINE | NDA 021077 | LABEL W CLIN | 36 | S | 9/19/2008 | 3/31/2009 | 6.3 |
| LOPINAVIR; RITONAVIR | ABBOTT LABORATORIES | NDA 021251 | LABEL W CLIN | 26 | S | 6/25/2008 | 4/20/2009 | 9.8 |
| LOPINAVIR; RITONAVIR | ABBOTT LABORATORIES | NDA 021906 | LABEL W CLIN | 17 | S | 6/25/2008 | 4/20/2009 | 9.8 |
| NICOTINE POLACRILEX | GLAXOSMITHKLINE | NDA 018612 | LABEL W CLIN | 52 | S | 7/8/2008 | 5/6/2009 | 9.9 |
| NICOTINE POLACRILEX | GLAXOSMITHKLINE | NDA 020066 | LABEL W CLIN | 33 | S | 7/8/2008 | 5/6/2009 | 9.9 |
| ASTELLAS PHARMA US INC | NDA 050708 | LABEL W CLIN | 27 | S | 2/14/2006 | 5/19/2009 | 39.1 | |
| ASTELLAS PHARMA US INC | NDA 050709 | LABEL W CLIN | 21 | P | 2/14/2006 | 5/19/2009 | 39.1 | |
| LISDEXAMFETAMINE DIMESYLATE | SHIRE DEVELOPMENT INC | NDA 021977 | LABEL W CLIN | 7 | S | 7/31/2008 | 5/22/2009 | 9.7 |
| OLOPATADINE HCL 0.6% | ALCON INC | NDA 021861 | LABEL W CLIN | 1 | S | 8/19/2008 | 6/17/2009 | 9.9 |
| ESOMEPRAZOLE MAGNESIUM 20/40MG | ASTRAZENECA LP | NDA 021957 | LABEL W CLIN | 5 | S | 12/18/2008 | 6/18/2009 | 6.0 |
| CASPOFUNGIN ACETATE | MERCK AND CO INC | NDA 021227 | LABEL W CLIN | 23 | S | 9/5/2008 | 6/26/2009 | 9.7 |
| ENTECAVIR TABLETS 0.5/1MG | BRISTOL MYERS SQUIBB | NDA 021797 | LABEL W CLIN | 8 | S | 9/26/2008 | 7/16/2009 | 9.6 |
| ENTECAVIR ORAL SOLUTION 0.05MG/ML | BRISTOL MYERS SQUIBB | NDA 021798 | LABEL W CLIN | 8 | S | 9/26/2008 | 7/16/2009 | 9.6 |
| RISEDRONATE SODIUM | PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO | NDA 020835 | LABEL W CLIN | 35 | P | 1/26/2009 | 7/23/2009 | 5.9 |
| INSULIN GLARGINE | SANOFI AVENTIS US LLC | NDA 021081 | LABEL W CLIN | 34 | S | 12/21/2007 | 9/9/2009 | 20.6 |
| OMEGA-3-ACID ETHYL ESTERS | SMITHKLINE BEECHAM | NDA 021654 | LABEL W CLIN | 22 | S | 9/5/2008 | 9/16/2009 | 12.4 |
| VORINOSTAT | MERCK AND CO INC | NDA 021991 | LABEL W CLIN | 4 | S | 2/10/2009 | 9/23/2009 | 7.4 |
| ASPIRIN; DIPYRIDAMOLE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | NDA 020884 | LABEL W CLIN | 18 | S | 12/2/2008 | 10/1/2009 | 10.0 |
| IXABEPILONE | BRISTOL MYERS SQUIBB CO | NDA 022065 | LABEL W CLIN | 2 | S | 12/12/2008 | 10/2/2009 | 9.7 |
| TENOFOVIR DISOPROXIL FUMARATE | GILEAD SCIENCES INC | NDA 021356 | LABEL W CLIN | 27 | S | 12/8/2008 | 10/7/2009 | 10.0 |
| (DIVALPROEX SODIUM)EXTENDED RELEASE TABS | ABBOTT LABORATORIES | NDA 022267 | LABEL W CLIN | 1 | S | 12/16/2008 | 10/15/2009 | 10.0 |
| METHYLPHENIDATE HYDROCHLORIDE | ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC | NDA 021121 | LABEL W CLIN | 22 | S | 12/23/2008 | 11/4/2009 | 10.4 |
| ATAZANAVIR SULFATE | BRISTOL MYERS SQUIBB CO | NDA 021567 | LABEL W CLIN | 19 | S | 1/5/2009 | 11/5/2009 | 10.0 |
| RASAGILINE MESYLATE | TEVA NEUROSCIENCE INC | NDA 021641 | LABEL W CLIN | 8 | S | 2/9/2009 | 12/9/2009 | 10.0 |
| TIOTROPIUM BROMIDE | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | NDA 021395 | LABEL W CLIN | 29 | S | 11/18/2008 | 12/17/2009 | 13.0 |
| TAMSULOSIN HCL | BOEHRINGER INGELHEIM PHARMACEUTICALS INC | NDA 020579 | LABEL W CLIN | 26 | P | 6/26/2009 | 12/22/2009 | 5.9 |
| FAMCICLOVIR | NOVARTIS PHARMACEUTICALS CORP | NDA 020363 | LABEL W CLIN | 36 | P | 6/30/2009 | 12/24/2009 | 5.8 |
| BORTEZOMIB | MILLENNIUM PHARMACEUTICALS INC | NDA 021602 | LABEL W CLIN | 19 | S | 7/1/2009 | 12/30/2009 | 6.0 |
| BORTEZOMIB | MILLENNIUM PHARMACEUTICALS INC | NDA 021602 | LABEL W CLIN | 20 | P | 7/2/2009 | 12/30/2009 | 6.0 |
BLA Efficacy Supplements Approved
| PROPER NAME | APPLICANT | BLA NUMBER | SUPPLEMENT NUMBER | PRIORITY REVIEW | RECEIPT DATE | APPROVAL DATE | TOTAL APPROVAL TIME (IN MONTHS) | INDICATION |
|---|---|---|---|---|---|---|---|---|
| OPRELVEKIN | WYETH PHARMACEUTICALS INC. | L 103694 | 1008 | S10 | 8/27/1999 | 2/13/2009 | 113.7 | REVISE THE CLINICAL PHARMACOLOGY: PHARMACOKINETICS SUBSECTION OF THE PACKAGE INSERT AND TO INCLUDE A GERIATRIC USE SUBSECTION |
| PEGINTERFERON ALFA-2B | SCHERING CORPORATION | L 103949 | 5125 | S10 | 8/1/2006 | 3/10/2009 | 31.3 | TO 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 |
| ABOBOTULINUMTOXINA | IPSEN BIOPHARM LIMITED | L 125274 | 1 | S10 | 3/14/2008 | 4/29/2009 | 13.5 | FORMERLY BLA 125286/0 -- (CONVERTED TO EFFICACY SUPPLEMENT UNDER THIS BLA) FOR TEMPORARY IMPROVEMENT IN THE APPEARANCE OF MODERATE TO SEVERE GLABELLAR LINES |
| BEVACIZUMAB | GENENTECH, INC. | L 125085 | 169 | P06 | 11/3/2008 | 5/5/2009 | 6.0 | INCLUDE A NEW INDICATION FOR BEVACIZUMAB FOR THE TREATMENT OF PATIENTS WITH GLIOBLASTOMA WITH PROGRESSIVE DISEASE FOLLOWING PRIOR THERAPY. |
| PEGINTERFERON ALFA-2B | SCHERING CORPORATION | L 103949 | 5172 | S10 | 7/8/2008 | 5/8/2009 | 10.0 | TO 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 PEGOL | UCB, INC. | L 125160 | 80 | S10 | 12/6/2007 | 5/13/2009 | 17.2 | NEW INDICATION FOR TREATMENT OF RHEUMATOID ARTHRITIS -- ORIGINALLY FILED AS STN 125271/0 |
| LARONIDASE | BIOMARIN PHARMACEUTICAL INC. | L 125058 | 160 | S10 | 12/10/2007 | 5/20/2009 | 17.3 | CHANGES TO ADVERSE REACTIONS, USE IN SPECIFIC POPULATIONS, CLINICAL PHARMACOLOGY, AND CLINICAL STUDIES SECTION OF THE PACKAGE INSERT. |
| LARONIDASE | BIOMARIN PHARMACEUTICAL INC. | L 125058 | 161 | S10 | 12/17/2007 | 5/20/2009 | 17.1 | UPDATE TO ADVERSE REACTIONS, CLINICAL PHARMACOLOGY, AND CLINICAL STUDIES SECTIONS OF THE PACKAGE INSERT WITH CLINICAL DATA. |
| BEVACIZUMAB | GENENTECH, INC. | L 125085 | 168 | S10 | 10/1/2008 | 7/31/2009 | 10.0 | NEW INDICATION FOR USE IN COMBINATION WITH INTERFERON ALFA FOR TREATMENT OF PATIENTS WITH METASTATIC RENAL CELL CARCINOMA |
| ABATACEPT | BRISTOL-MYERS SQUIBB | L 125118 | 86 | S10 | 10/27/2008 | 8/25/2009 | 9.9 | ADVERSE REACTIONS: CLINICAL EXPERIENCE IN MTX-NAIVE PATIENTS AND CLINICAL STUDIES: ADULT RHEUMATOID ARTHRITIS SECTIONS OF THE PACKAGE INSERT. |
| IBRITUMOMAB TIUXETAN | SPECTRUM PHARMACEUTICALS, INC. | L 125019 | 156 | P06 | 10/1/2008 | 9/3/2009 | 11.1 | NEW INDICATION FOR PATIENTS WITH CD20 POSITIVE FOLLICULAR NON-HODGKIN'S LYMPHOMA WHO ACHIEVED A COMPLETE OR PARTIAL RESPONSE FOLLOWING FIRST-LINE CHEMOTHERAPY |
| ETANERCEPT | IMMUNEX CORPORATION | L 103795 | 5378 | S10 | 9/26/2007 | 9/30/2009 | 24.2 | ADDITION OF LONG TERM SAFETY DATA FOR THE ADULT PSORIASIS INDICATION |
| RITUXIMAB | GENENTECH, INC. | L 103705 | 5299 | S10 | 9/16/2008 | 10/16/2009 | 13.0 | ADDITION OF "IMPROVEMENT OF PHYSICAL FUNCTION" CLAIM |
| RASBURICASE | SANOFI-AVENTIS U.S. LLC | L 103946 | 5083 | S10 | 12/17/2008 | 10/16/2009 | 10.0 | NEW INDICATION FOR INITIAL MANAGEMENT OF PLASMA URIC ACID LEVELS IN ADULT PATIENTS WITH LEUKEMIA, LYMPHOMA, & SOLID TUMOR MALIGNANCIES WHO ARE RECEIVING ANTI-CANCER THERAPY EXPECTED TO RESULT IN TUMOR LYSIS & SUBSEQUENT ELEVATION OF PLASMA URIC ACID |
This information has been provided by CDER/OPI/OBI/Division of Business Analysis and Reporting (DBAR). If you have any questions regarding this report, please send an email to BARS@fda.gov
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