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EFFICACY SUPPLEMENTS APPROVED IN FISCAL YEAR 2004
(SE1 -SE7)*

 

Generic Name Applicant NDA Number Supp Type Supp Number Priority Review Receipt Date Approval Date Total Approval Time (Months) Indication/Description
eplerenone GD Searle 021437 SE1 002 Y 4/7/2003 10/7/2003 6 Provides for the use of Inspra (eplerenone) Tablets to 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.
penciclovir Novartis 020629 SE5 008   12/11/2002 10/10/2003 10 Provides for the use of Denavir (penciclovir cream) 1% for the treatment of recurrent herpes labialis (RHL) in children 12 and older.
paroxetine hydrochloride GlaxoSmithKline 020936 SE1 012   12/20/2002 10/16/2003 9.9 Provides for the use of Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets for the treatment of social anxiety disorder.
nateglinide Novartis 021204 SE1 006   12/20/2002 10/20/2003 10 Provides for an expanded indication for the use of Starlix (nateglinide) Tablets, in combination with antidiabetic drugs in the thiazolidinedione class.
levofloxacin Ortho McNeil 020635 SE2 027   12/23/2002 10/23/2003 10 Provides for the use of Levaquin Injection for Community Acquired Pneumonia (CAP) with a new dosing regimen of 750 mg once daily for 5 days.
levofloxacin Ortho McNeil 020634 SE2 028   12/23/2002 10/23/2003 10 Provides for the use of Levaquin Tablets for Community Acquired Pneumonia (CAP) with a new dosing regimen of 750 mg once daily for 5 days.
voriconazole Pfizer 021466 N 000   11/17/2000 11/14/2003 35.9 Provides for the use of VFEND (voriconazole for injection) I.V. for esophageal candidiasis.
voriconazole Pfizer 021464 N 000   11/17/2000 11/14/2003 35.9 Provides for the use of VFEND (voriconazole) Tablets for esophageal candidiasis.
salmeterol/fluticasone propionate GlaxoSmithKline 021077 SE1 003   5/7/2001 11/17/2003 30.4 Provides for the use of Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate inhalation powder) for Chronic Obstructive Pulmonary Disease associated with Chronic Bronchitis.
loratadine Schering 020641 SE6 011   1/28/2002 11/19/2003 21.7 Provides for over-the-counter use of Claritin (loratadine) Syrup for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.
loratadine Schering 020704 SE6 009   1/28/2002 11/19/2003 21.7 Provides for over-the-counter use of Claritin (loratadine) Reditabs for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.
loratadine Schering 019658 SE6 020   1/28/2002 11/19/2003 21.7 Provides for over-the-counter use of Claritin (loratadine) Tablets for the relief of itching due to hives (urticaria) to be marketed under the tradename, Claritin Hives Relief.
somatropin [rDNA origin] Serono 021597 N 000   11/1/2002 12/1/2003 13 Provides for the use of Zorbtive [somatotropin (rDNA origin) for injection] for the treatment of Short Bowel Syndrome in patients receiving specialized nutritional support.
atovaquone; proguanil hydrochloride GlaxoSmithKline 021078 SE5 006 Y 6/2/2003 12/2/2003 6 Provides for the use of Malarone (atovaquone and proguanil hydrochloride) Pediatric Tablets, 62.5 mg/25 mg for the treatment of Plasmodium falciparum malaria in pediatric patients weighing 5 kg to 11 kg.
risperidone Janssen 020588 SE1 018   12/16/2002 12/4/2003 11.6 Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (oral suspension)
risperidone Janssen 020588 SE1 017   12/16/2002 12/4/2003 11.6 Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (oral suspension)
risperidone Janssen 020272 SE1 027   12/16/2002 12/4/2003 11.6 Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (tablets)
risperidone Janssen 020272 SE1 026   12/16/2002 12/4/2003 11.6 Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (tablets)
risperidone Janssen 021444 SE1 002   8/15/2003 12/4/2003 3.6 Provides for Monotherapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (orally disintegrating tablets)
risperidone Janssen 021444 SE1 003   8/15/2003 12/4/2003 3.6 Provides for Adjunctive Therapy - for short term treatment of acute manic or mixed episodes associated with Bipolar I Disorder (orallly disintegrating tablets)
imatinib mesylate Novartis 021588 SE7 002   8/28/2003 12/8/2003 3.4 Provides for a revised package insert with updated data and fulfills the prior accelerated postmarketing commitment #2 under NDA 21-588/N-000 "To provide interval follow-up information on studies 102, 109 and 110" for the use of Gleevec (imatinib mesylate) Tablets for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alfa therapy.
dalteparin sodium Pharmacia & Upjohn 020287 SE1 032   2/10/2003 12/10/2003 10 Provides for the use of Fragmin (dalteparin sodium) injection for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
orlistat HLR 020766 SE5 018 Y 6/24/2003 12/12/2003 5.6 Provides for revised labeling to provide for use of Xenical Capsules in the management of obesity in adolescent patients aged 12 to 16 years.
topiramate Ortho McNeil 020505 SE2 017   7/1/2002 12/16/2003 17.5 Provides for a change in the recommended daily dose of topiramate and an update to the relevant clinical/safety sections of labeling based on results of the TOPMAT-EPAJ-119 study.
topiramate Ortho Mcneil 020844 SE2 014   7/1/2002 12/16/2003 17.5 Provides for a change in the recommended daily dose of topiramate and an update to the relevant clinical/safety sections of labeling based on results of the TOPMAT-EPAJ-119 study.
escitalopram oxalate Forest 021323 SE1 003   11/27/2002 12/18/2003 12.7 Provides for the treatment of generalized anxiety disorder (tablets).
escitalopram oxalate Forest 021365 SE1 004   5/22/2003 12/18/2003 6.9 Provides for the treatment of generalized anxiety disorder (oral solution).
saquinavir HLR 020628 SE2 020   2/24/2003 12/24/2003 10 Provides for the use of INVIRASE (1000 mg twice daily) coadministered with ritonavir (100 mg twice daily) and in combination with other antiretroviral drugs, for the treatment of HIV infection.  The new dosing regimen replaces the previously approved regimen for INVIRASE.
saquinavir HLR 020828 SE2 015   2/24/2003 12/24/2003 10 Provides for the use of an additional dosing regimen of FORTOVASE (saquinavir) Soft Gelatin Capsules (1000 mg twice daily coadministered with ritonavir 100 mg twice daily) and in combination with other antiretroviral drugs, for the treatment of HIV infection.
amlodipine besylate Pfizer 019787 SE5 030   9/17/01 1/8/04 27.7 Provides for changes in the CLINICAL PHARMACOLOGY, INDICATIONS AND USAGE, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling concerning use of Norvasc (amlodipine besylate) 2.5 mg to 5 mg tablets in pediatric patients with hypertension.
oxaliplatin Sanofi 021492 SE1 002 Y 7/11/03 1/9/04 6.0 Provides for the use of Eloxatin in combination with infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) for the treatment of patients previously untreated for advanced colorectal cancer
quetiapine fumarate AstraZeneca 020639 SE1 016   12/30/02 1/12/04 12.4 Provides for the use of Seroquel (quetiapine fumarate) tablets as monotherapy in the treatment of acute manic episodes associated with Bipolar I disorder
quetiapine fumarate AstraZeneca 020639 SE1 017   12/30/02 1/12/04 12.4 Provides for the use of Seroquel (quetiapine fumarate) tablets as adjunctive therapy with mood stabilizers (lithium or divalproex) in the treatment of acute manic episodes associated with Bipolar I disorder
olanzapine Lilly 020592 SE1 019   11/21/02 1/14/04 13.8 Provides for the use of olanzapine in the long-term treatment of bipolar I disorder
azithromycin Pfizer 050784 SE1 004   3/17/03 1/15/04 10.0 Provides for treatment of acute bacterial sinusitis using a 3-day regimen of Zithromax (azithromycin) Tablets, 500 mg 
modafinil Cephalon 020717 SE1 008   12/20/02 1/23/04 13.1 Provides for the use of Provigil (modafinil) Tablets 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
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