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Efficacy Supplement Approvals in 2002

EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002
(SE1 -SE7)*

and

EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002
(SE8)*

 

GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY
REVIEW 
TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION
ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX (anastrozole) Tablets for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
ARGATROBAN TEXAS BIOTECH 20-883 SE1 004 18-Dec-00 3-Apr-02 Y 15.5 Proposes the use of Argatroban Injection "in patients undergoing percutaneous coronary interventions (PCI) who have or are at risk for heparin-induced thrombocytopenia."
ATORVASTATIN CALCIUM PFIZER 20-702 SE5 033 19-Dec-01 18-Oct-02   10.0 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 10 to 20 mg once daily.
BECLOMETHASONE DIPROPIONATE HFA 3M PHARMS 20-911 SE5 005 10-Jul-01 10-May-02   10.0 Provides for the use of QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol for maintenance treatment of asthma in children 5 through 11 years of age.
CANDESARTAN CILEXETIL ASTRAZENECA 20-838 SE4 015 27-Sep-01 13-Sep-02   11.5 Provides data on the comparison of the antihypertensive effects of Atacand (candesartan cilexetil) Tablets and Cozaar (losartan potassium) Tablets. It also proposes revisions to the CLINICAL PHARMACOLOGY, (Clinical Trials & Special Populations), PRECAUTIONS, OVERDOSAGE, and DOSAGE AND ADMINISTRATION sections of the labeling.
CASPOFUNGIN ACETATE MERCK RES 21-227 SE1 001 8-May-01 20-Sep-02   16.4 Provides for the use of Cancidas (caspofungin acetate) For Injection for the treatment of esophageal candidiasis.
CEFDITOREN PIVOXIL TAP PHARM 21-222 SE1 001 2-Nov-01 21-Aug-02   9.6 Provides for the use of Spectracef (cefditoren pivoxil) Tablets for the treatment of community-acquired pneumonia in adults.
CETIRIZINE HYDROCHLORIDE PFIZER 19-835 SE5 015 21-Dec-01 21-Oct-02   10.0 Provides for the use of Zyrtec (cetirizine hydrochloride) Tablets for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. Also provides for the use of Zyrtec (cetirizine hydrochloride) Tablets for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
CETIRIZINE HYDROCHLORIDE PFIZER 20-346 SE5 008 21-Dec-01 21-Oct-02   10.0 Provides for the use of Zyrtec (cetirizine hydrochloride) Syrup for the relief of symptoms associated with perennial allergic rhinitis in adults and children 6 months of age and older. Also provides for the use of Zyrtec (cetirizine hydrochloride) Syrup for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
CLARITHROMYCIN ABBOTT LABS 50-697 SE7 002 27-Jul-01 24-May-02   9.9 Provides for the treatment of disseminated mycobacterial infections due to  Mycobacterium avium and  Mycobacterium intracellulare.
CLARITHROMYCIN ABBOTT LABS 50-698 SE7 014 30-Jul-01 24-May-02   9.8 Provides for the treatment of disseminated mycobacterial infections due to  Mycobacterium avium and  Mycobacterium intracellulare.
CLOBETASOL PROPIONATE CONNETICS 21-142 SE1 004 26-Dec-01 20-Dec-02   11.8 Proposes the use of OLUX (clobetasol propionate) Foam, 0.05%, for an expanded labeling of the Indications & Usage Section which includes the original labeled wording along with the statement "and for short term topical treatment of mild to moderate plaque-type psoriasis of non-scalp regions".
CLOPIDOGREL BISULFATE SANOFI SYNTHELABO 20-839 SE1 019 21-Aug-01 27-Feb-02 Y 6.2 Provides for the use of Plavix (clopidogrel bisulfate) Tablets in Acute Coronary Syndrome.
CLOZAPINE NOVARTIS PHARMS 19-758 SE1 047 1-Mar-02 18-Dec-02 Y 9.6 Provides for the use of Clozaril (clozapine) tablets to treat patients with schizophrenia or schizoaffective disorder at risk for emergent suicidal behavior.
DESLORATADINE SCHERING 21-297 N 000 31-Aug-00 8-Feb-02   17.3 Provides for the use of Clarinex (desloratadine) Tablets for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.
DESLORATADINE SCHERING 21-363 N 000 10-Apr-01 8-Feb-02   10.0 Provides for the use of Clarinex (desloratadine) Tablets for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.
DEXRAZOXANE FOR INJECTION PHARMACIA AND UPJOHN 20-212 SE7 006 31-Dec-01 31-Oct-02   10.0 Provides support for conversion of ZINECARD for Injection (dexrazoxane for injection) from accelerated to regular approval.
DOCETAXEL AVENTIS PHARMS 20-449 SE1 018 1-Feb-02 27-Nov-02   9.8 Provides for the use of TAXOTERE in combination with ciplatin 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. Also proposes revisions in the Human Pharmacokinetics section.
DUTASTERIDE GLAXOSMITHKLINE 21-319 SE1 001 13-Dec-01 9-Oct-02   9.9 Provides for the use of AVODART (dutasteride soft-gelatin capsules) for the treatment of symptomatic 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 for BPH-related surgery.
ESCITALOPRAM OXALATE FOREST LABS 21-440 N 000 29-Oct-01 29-Aug-02   10.0 Provides for labeling revisions to include prevention of relapse following long-term treatment of major depressive disorder.
ESTRADIOL TRANSDERMAL SYSTEM NOVARTIS PHARMS 20-538 SE1 015 23-Jan-01 3-May-02   15.3 Proposes changes for the use of Vivelle-Dot as follows: Addition of the prevention of postmenopausal osteoporosis indication in at-risk patients for the .025 mg/day strength.
FLUOXETINE HYDROCHLORIDE LILLY RES LABS 18-936 SE2 067 23-Mar-01 12-Jun-02   14.7 Provides for the use of Sarafem in the treatment of premenstrual dysphoric disorder (PMDD), using an intermittent dosing regimen, as an alternative to the currently approved continuous dosing regimen.
FLUOXETINE HYDROCHLORIDE LILLY 18-936 SE1 061 27-Jul-00 29-Jul-02   24.1 Provides for the treatment of panic disorder, with or without agoraphobia.
FLUTICASONE PROPIONATE GLAXOSMITHKLINE 19-957 SE5 011 20-Mar-01 18-Jan-02   10.0 Provides for revisions in labeling to include pediatric usage in pediatric patients age 3 months and older.
FLUTICASONE PROPIONATE GLAXOSMITHKLINE 20-121 SE2 023 24-Jul-01 23-May-02   10.0 Provides for the use of Flonase Nasal Spray 50 mcg on an "as needed" or PRN basis for the management of nasal symptoms in patients for whom the drug is indicated.
FOLLITROPIN BETA ORGANON 20-582 SE1 006 9-Apr-01 26-Feb-02 **   10.6 Provides a tentative approval for the use of Follistim (follitropin beta for injection) for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
GABAPENTIN PFIZER PHARMS 21-397 N 000 7-Aug-01 24-May-02   9.5 Provides for the use of Neurontin (gabapentin) capsules for the management of postherpetic neuralgia.
GABAPENTIN PFIZER PHARMS 21-423 N 000 17-Aug-01 24-May-02   9.2 Provides for the use of Neurontin (gabapentin) tablets for the management of postherpetic neuralgia.
GABAPENTIN PFIZER PHARMS 21-424 N 000 17-Aug-01 24-May-02   9.2 Provides for the use of Neurontin (gabapentin) oral solution for the management of postherpetic neuralgia.
GATIFLOXACIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 21-404 N 000 28-Dec-98 17-Oct-02   45.7 Provides for the use of Tequin Tablets for the treatment of uncomplicated skin and skin structure infections.
GATIFLOXACIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 21-405 N 000 28-Dec-98 17-Oct-02   45.7 Provides for the use of Tequin Injection for the treatment of uncomplicated skin and skin structure infections.
GLYBURIDE AND METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 21-178 SE1 004 30-Nov-01 30-Sep-02   10.0 Provides for the use of Glucovance (Glyburide and Metformin HCl) tablets with a thiazolidinedione when glycemic control is not obtained with Glucovance alone.
GRANISETRON HYDROCHLORIDE ROCHE 20-239 SE1 008 22-Oct-01 16-Aug-02    9.8 Provides for the use of KYTRIL (granisetron HCL) Injection for the prevention and treatment of postoperative nausea and vomiting.
IMATINIB MESYLATE NOVARTIS PHARMS 21-335 SE1 001 16-Oct-01 1-Feb-02   3.6 Provides for the use of Gleevec (imatinib mesylate) for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
IMATINIB MESYLATE NOVARTIS PHARMS 21-335 SE1 004 28-Jun-02 20-Dec-02 Y 5.8 Provides for the use of Gleevec (imatinib mesylate), 100 mg capsules for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML). Follow-up is limited.
IRBESARTAN SANOFI SYNTHELABO 20-757 SE1 021 3-Aug-01 17-Sep-02 Y 13.5 Provides for the use of Avapro (irbesartan) Tablets, 75, 150 and 300 mg for the treatment of type 2 diabetic nephropathy.
KETOROLAC TROMETHAMINE ALLERGAN 19-700 SE5 019 19-Jun-01 8-Feb-02   7.7 Proposes a change in the wording of the pediatric section of the package inserts.
KETOROLAC TROMETHAMINE ALLERGAN 20-811 SE5 003 19-Jun-01 8-Feb-02   7.7 Proposes a change in the wording of the pediatric section of the package inserts.
LAMIVUDINE GLAXOSMITHKLINE 20-564 SE2 015 31-Aug-01 24-Jun-02   9.8 Provides for a new higher strength 300 mg tablet.
LAMIVUDINE GLAXOSMITHKLINE 20-596 SE2 016 31-Aug-01 24-Jun-02   9.8 Provides for the use of Epivir (lamivudine) once daily for the treatment of HIV infection in combination with other antiretroviral agents.
LANSOPRAZOLE TAP PHARM 20-406 SE5 047 31-Jan-02 31-Jul-02 Y 6.0 Provides for the following changes in the Prevacid (lansoprazole) package insert: pediatric labeling for the 1 to 11 year age group by updating the Clinical Pharmacology, Clinical Studies, Indication and Usage, Precautions, Adverse Events, and Dosage and Administration sections.
LATANOPROST OPHTHALMIC SOLUTION PHARMACIA AND UPJOHN 20-597 SE1 010 1-Jul-99 20-Dec-02 Y 41.7 Provides for the use of Xalatan (latanoprost ophthalmic solution) for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
LEVALBUTEROL HYDROCHLORIDE SEPRACOR 20-837 SE5 006 30-Mar-01 30-Jan-02   10.1 Provides for the use of Xopenex (levalbuterol inhalation solution) for the treatment or prevention of bronchospasm in children 6 years of age and older with reversible obstructive airway disease.
LEVOFLOXACIN ORTHO MCNEIL PHARM 20-634 SE1 025 31-Dec-01 30-Oct-02   10.0 Provides for the use of Levaquin Tablets for the treatment of nosocomial pneumonia.
LEVOFLOXACIN ORTHO MCNEIL PHARM 20-635 SE1 022 31-Dec-01 30-Oct-02   10.0 Provides for the use of Levaquin Injection for the treatment of nosocomial pneumonia.
LEVONORGESTREL POPULATION COUNCIL 20-544 SE2 003 26-Sep-00 22-Nov-02   25.9 Proposes an extension of the approved duration of use of Jadelle (levonorgestrel) Implants for the prevention of pregnancy from "up to 3 years" to "up to 5 years."
LINEZOLID PHARMACIA AND UPJOHN 21-130 SE5 003 24-Jun-02 19-Dec-02 Y 5.9 Provides for the use of Zyvox (linezolid) Tablets for the treatment of pediatric patients with nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant  Enterococcus faecium infections.
LINEZOLID PHARMACIA AND UPJOHN 21-131 SE5 003 24-Jun-02 19-Dec-02 Y 5.9 Provides for the use of Zyvox (linezolid) I.V. Injection for the treatment of pediatric patients with nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant  Enterococcus faecium infections.
LINEZOLID PHARMACIA AND UPJOHN 21-132 SE5 003 24-Jun-02 19-Dec-02 Y 5.9 Provides for the use of Zyvox (linezolid) for Oral Suspension for the treatment of pediatric patients with nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant  Enterococcus faecium infections.
LOPINAVIR/RITONAVIR ABBOTT LABS 21-226 SE7 006 31-Jan-02 27-Nov-02   9.9 Provides for the use of KALETRA Capsules in combination with other antiretroviral agents for the treatment of HIV-infection.
LOPINAVIR/RITONAVIR ABBOTT LABS 21-251 SE7 005 31-Jan-02 27-Nov-02   9.9 Provides for the use of KALETRA Oral Solution in combination with other antiretroviral agents for the treatment of HIV-infection.
LORATADINE SCHERING 19-658 SE6 018 28-Jan-02 27-Nov-02   10.0 Provides for the over-the-counter use of Claritin (loratadine) Tablets for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, and itching of the nose or throat.
LORATADINE SCHERING 20-641 SE6 009 28-Jan-02 27-Nov-02   10.0 Provides for the over-the-counter use of Claritin (loratadine) Syrup for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, and itching of the nose or throat.
LORATADINE SCHERING 20-704 SE6 008 28-Jan-02 27-Nov-02   10.0 Provides for the over-the-counter use of Claritin (loratadine) RediTabs for the temporary relief of symptoms of hay fever or other upper respiratory allergies: runny nose, sneezing, itchy, watery eyes, and itching of the nose or throat.
LORATADINE/ PSEUDOEPHEDRINE SULFATE SCHERING 19-670 SE6 018 28-Jan-02 27-Nov-02   10.0 Provides for the over-the-counter use of Claritin (loratadine/pseudoephedrine sulfate) D-12 Extended Release for the temporary relief of symptoms of hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat; temporary reduction of swelling of nasal passages; temporary relief of sinus pressure; and temporary restoration of freer breathing through the nose.
LORATADINE/ PSEUDOEPHEDRINE SULFATE SCHERING 20-470 SE6 016 28-Jan-02 27-Nov-02   10.0 Provides for the over-the-counter use of Claritin (loratadine/pseudoephedrine sulfate) D-24 Extended Release for the temporary relief of symptoms of hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat; temporary reduction of swelling of nasal passages; temporary relief of sinus pressure; and temporary restoration of freer breathing through the nose.
LOSARTAN POTASSIUM MERCK 20-386 SE1 028 13-Nov-01 17-Sep-02 Y 10.1 Provides for the use of Cozaar (losartan potassium) 25, 50 and 100 mg Tablets for the treatment of type 2 diabetic nephropathy.
LOVASTATIN MERCK 19-643 SE5 067 17-Apr-01 14-Feb-02   10.0 Provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in a new population of adolescent boys and girls at least one year postmenarchal, ages 10 to 17 years, with a recommended dosing range of 10 to 40 mg once daily of Mevacor (lovastatin) tablets.
LOVASTATIN ANDRX 21-316 SE1 001 30-Mar-01 11-Sep-02   17.4 Provides for the use of Altocor (lovastatin) Extended-Release Tablets in the primary prevention of coronary heart disease in patients who have average to moderately elevated Total-C and LDL-C and below average HDL-C.
MOMETASONE FUROATE SCHERING 19-543 SE5 013 17-Sep-01 17-Jul-02   10.0 Provides for a completed pediatric study report in response to the issued written request dated March 17, 1999, and revised on December 15, 2000, and September 5, 2001.
MOMETASONE FUROATE SCHERING 19-625 SE5 013 17-Sep-01 17-Jul-02   10.0 Provides for a completed pediatric study report in response to the issued written request dated March 17, 1999, and revised on December 15, 2000, and September 5, 2001.
MOMETASONE FUROATE SCHERING 19-796 SE5 015 17-Sep-01 17-Jul-02   10.0 Provides for a completed pediatric study report in response to the issued written request dated March 17, 1999, and revised December 15, 2000, and September 5, 2001.
MOMETASONE FUROATE SCHERING PLOUGH 20-762 SE5 011 17-Sep-01 17-Jul-02   10.0 Provides for the use of Nasonex (mometasone furoate) 50 mcg Nasal Spray in treatment of seasonal and perennial allergic rhinitis in children down to 2 years of age.
MONTELUKAST SODIUM MERCK RES LABS 20-829 SE1 017 1-Mar-02 31-Dec-02   10.0 Provides for the use of Singulair Tablets for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.
MONTELUKAST SODIUM MERCK RES LABS 20-830 SE1 020 1-Mar-02 31-Dec-02   10.0 Provides for the use of Singulair Chewable Tablets for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.
MONTELUKAST SODIUM MERCK RES LABS 21-409 SE1 003 16-Dec-02 31-Dec-02   0.5 Provides for the use of Singulair Oral Granules for the relief of symptoms of seasonal allergic rhinitis in pediatric patients 2 to 5 years of age.
NEVIRAPINE BOEHRINGER INGELHEIM PHARMS 20-636 SE7 017 31-May-01 27-Mar-02   9.9 Provides for the use of Viramune (nevirapine) tablets and oral solution in combination with other antiretroviral agents for the treatment of HIV-1 infection.
NEVIRAPINE BOEHRINGER INGELHEIM PHARMS 20-933 SE7 007 16-Aug-01 27-Mar-02   7.3 Provides for the use of Viramune (nevirapine) tablets and oral solution in combination with other antiretroviral agents for the treatment of HIV-1 infection.
NICOTINE TRANSDERMAL SYSTEM PHARMACIA CONSUMER HEALTHCARE 20-150 SE6 011 21-May-01 21-Mar-02   10.0 Provides for the Over-the-Counter (OTC) marketing of Nicotrol TD step-down regimen for adults 18 years of age and older, to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.
OMEPRAZOLE ASTRAZENECA 19-810 SE5 074 22-Dec-00 12-Jul-02   18.6 Provides for revisions to the  CLINICAL PHARMACOLOGY, Pharmacokinetics and  Metabolism: Omeprazole, PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility, Pediatric Use, and  DOSAGE AND ADMINISTRATION sections of the labeling to add information regarding the use of Prilosec in pediatric patients 2 years of age and older.
OXAPROZIN SEARLE 18-841 SE5 016 12-Oct-99 25-Jan-02   27.5 Provides for proposed pediatric labeling revisions in accordance with 21 CFR 314.70(b) and in response to the FDA's March 5, 1999 Pediatric Written Request.
PANTOPRAZOLE SODIUM WYETH AYERST 20-987 SE1 007 22-Jun-01 19-Apr-02   9.9 Provides for the use of PROTONIX (pantoprazole sodium) Delayed-Release Tablets for pathological hypersecretory conditions including Zollinger-Ellison Syndrome.
PAROXETINE HYDROCHLORIDE GLAXOSMITHKLINE 20-982 N 000 22-Apr-98 12-Feb-02   45.8 Provides for the use of Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets for Panic Disorder.
PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB 19-898 SE5 052 6-May-02 29-Oct-02 Y 5.8 Provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in children, ages 8 to 13 years, with a recommended dose of 20 mg once daily and in adolescents, ages 14 to 18, with a recommended dose of 40 mg once daily.
RABEPRAZOLE SODIUM EISAI (US) 20-973 SE1 009 12-Apr-01 12-Feb-02   10.1 Provides for the use of Aciphex (rabeprazole sodium) Delayed-Release Tablets for the treatment of symptomatic gastroesophageal reflux disease (GERD).
RABEPRAZOLE SODIUM EISAI MEDCL RES 21-456 N 000 10-Jan-02 8-Nov-02   9.9 Provides for the use of ACIPHEX (rabeprazole sodium) Delayed-Release Tablets for the eradication of  Helicobacter pylori.
REPAGLINIDE NOVO NORDISK PHARM 20-741 SE1 013 21-Dec-01 21-Oct-02   10.0 Provides for the use of Prandin (repaglinide) Tablets in combination with a thiazolidinedione to lower blood glucose in patients with type 2 diabetes whose hyperglycemia cannot be controlled by diet and exercise plus monotherapy with any of the following agents: metformin, sulfonylureas, repaglinide, or thiazolidinediones. Also provides for the addition of pharmacokinetic information on the co-administration of clarithromycin and repaglinide to the  CLINICAL PHARMACOLOGY and  PRECAUTIONS sections of the package insert.
RISEDRONATE SODIUM PROCTER GAMBLE PHARM 20-835 SE2 008 25-Jul-01 17-May-02   9.7 Provides for once-a-week dosing of Actonel (risedronate sodium) 35 mg Tablets for the treatment of postmenopausal osteoporosis.
RISEDRONATE SODIUM PROCTER GAMBLE PHARM 20-835 SE2 009 25-Jul-01 17-May-02   9.7 Provides for once-a-week dosing of Actonel (risedronate sodium) 35 mg Tablets for the prevention of postmenopausal osteoporosis.
ROFECOXIB MERCK RES 21-042 SE1 012 1-Mar-01 11-Apr-02   13.3 Provides for indication of rheumatoid arthritis.
ROFECOXIB MERCK RES 21-052 SE1 007 1-Mar-01 11-Apr-02   13.3 Provides for indication of rheumatoid arthritis.
SALMETEROL XINAFOATE GLAXOSMITHKLINE 20-692 SE1 016 25-May-01 22-Mar-02   9.9 Provides for the use of Serevent Diskus (salmeterol xinafoate) inhalation powder for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).
SECRETIN CHIRHOCLIN 21-209 N 000 17-Aug-99 4-Apr-02 Y 31.6 Provides for the use of SecreFlo (secretin) for Injection for: the use in secretin stimulation testing for stimulation of gastrin secretion to aid in the diagnosis of gastrinoma.
SECRETIN CHIRHOCLIN 21-136 SE1 001 3-May-02 1-Nov-02 Y 6.0 Provides for the use of SecreFlo (secretin) Injection for use in secretin stimulation testing for: Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangio-pancreatography (ERCP).
SERTRALINE PFIZER PHARMS 19-839 SE1 039 1-Feb-01 16-May-02   15.4 Provides for the use of Zoloft Tablets in the treatment of Premenstrual Dysphoric Disorder (PMDD).
SERTRALINE PFIZER PHARMS 20-990 SE1 007 1-Feb-01 16-May-02   15.4 Provides for the use of Zoloft Oral Concentrate in the treatment of Premenstrual Dysphoric Disorder (PMDD).
SIMVASTATIN MERCK 19-766 SE5 056 21-Dec-01 18-Oct-02   9.9 Provides for the addition of an indication for the treatment of heterozygous familial hypercholesterolemia in a new population of adolescent boys and girls at least one year postmenarchal, ages 10 to 17 years, with a recommended dosing range of 10 to 40 mg once daily of Zocor (simvastatin) tablets.
SYNTHETIC CONJUGATED ESTROGENS, A DURAMED PHARMS BARR 20-992 SE1 016 17-Aug-01 21-Jun-02   10.1 Proposes the use of Cenestin 0.3 mg strength tablet for the treatment of vulvar and vaginal atrophy associated with the menopause.
TAMOXIFEN CITRATE ASTRAZENECA 21-109 N 000 1-Mar-02 30-Aug-02 Y 6.0 Provides the pediatric clinical study report that responded to a Written Request dated April 5, 2000, for tamoxifen citrate 20 mg tablets to obtain safety, efficacy, and pharmacokinetic information in girls with McCune-Albright Syndrome.
TAZAROTENE ALLERGAN 21-184 SE1 002 29-Jun-01 30-Sep-02   15.1 Proposes the use of AVAGE (tazarotene) Cream, 0.1%, as an adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients who use comprehensive skin care and sunlight avoidance programs.
TRETINOIN JOHNSON AND JOHNSON 20-475 SE2 008 12-Jul-01 10-May-02   9.9 Provides for a lower strength of tretinoin gel and is indicated for topical application for the treatment of acne vulgaris.
VALACYCLOVIR HYDROCHLORIDE GLAXOSMITHKLINE 20-550 SE1 016 14-Nov-01 9-Sep-02   9.8 Provides for the use of Valtrex (valacyclovir hydrochloride) for the treatment of cold sores (herpes labialis) in adult and adolescent patients 12 years of age and older.
VALPROATE SODIUM ABBOTT LABS 20-593 SE2 006 3-Jul-00 24-Jan-02   18.7 Provides for an increased rate of infusion for Depacon (valproate sodium injection).
VALSARTAN NOVARTIS PHARMS 20-665 SE1 016 27-Apr-01 14-Aug-02   15.6 Provides for the use of Diovan (valsartan) Capsules for the treatment of heart failure (NYHA class II-IV) in patients who are intolerant to an ACE (angiotensin converting enzyme) inhibitor.
VALSARTAN NOVARTIS PHARMS 21-283 SE1 001 23-Jul-01 14-Aug-02   12.7 Provides for the use of Diovan (valsartan) Tablets for the treatment of heart failure (NYHA class II-IV) in patients who are intolerant to an ACE (angiotensin converting enzyme) inhibitor. Provides for a new 40 mg tablet strength.
ZOLEDRONIC ACID NOVARTIS PHARMS 21-386 N 000 22-Aug-01 22-Feb-02 Y 6.0 Provides for the use of Zometa (zoledronic acid for injection) 4 mg, for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy.

 

*Supplement Type
N (Chemical Type 6)
SE1
SE2
SE3
SE4
SE5
SE6
SE7
NDA Type 6 - New Indication
New or modified indication
New dosage regimen
New route of administration
Comparative efficacy claim
Patient population altered
Change the marketing status from prescription to over the counter use
Complete the traditional approval of a product originally approved under Subpart H (accelerated approval)

           ** N20582, Follitropin Beta, SE1 006 was tentatively approved on February 26, 2002.

            This list is updated quarterly.  Updated through 12/31/02

    
          

 

 EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002
(SE8)*
GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS)
ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8 002 9-Apr-01 5-Feb-02   9.9
AGENERASE GLAXOSMITHKLINE 21-007 SE8 010 5-Apr-01 5-Feb-02   10.1
AGENERASE GLAXOSMITHKLINE 21-039 SE8 009 5-Apr-01 5-Feb-02   10.1
ALOSETRON HYDROCHLORIDE GLAXOSMITHKLINE 21-107 SE8 005 7-Dec-01 7-Jun-02 Y 6.0
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE NOVARTIS PHARMS 20-364 SE8 016 2-Jul-01 20-Jun-02   11.6
ATORVASTATIN CALCIUM PFIZER 20-702 SE8 029 31-Aug-01 22-Apr-02   7.7
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE GLAXOSMITHKLINE 21-078 SE8 003 9-Oct-01 2-Aug-02   9.8
CELECOXIB GD SEARLE LLC 20-998 SE8 009 14-Jun-00 7-Jun-02   23.8
DIDANOSINE BRISTOL MYERS SQUIBB 21-183 SE8 002 29-Mar-01 29-Jan-02   10.1
DIDANOSINE BRISTOL MYERS SQUIBB 20-154 SE8 037 1-Jun-01 1-Apr-02   10.0
DIDANOSINE BRISTOL MYERS SQUIBB 20-155 SE8 028 1-Jun-01 1-Apr-02   10.0
DIDANOSINE BRISTOL MYERS SQUIBB 20-156 SE8 029 1-Jun-01 1-Apr-02   10.0
DIDANOSINE BRISTOL MYERS SQUIBB 21-183 SE8 003 1-Jun-01 1-Apr-02   10.0
ESCITALOPRAM OXALATE FOREST LABS 21-323 SE8 001 23-Aug-02 29-Aug-02   0.2
ESTRADIOL TRANSDERMAL SYSTEM NOVARTIS PHARMS 20-538 SE8 014 19-Jan-01 3-May-02   15.4
FAMOTIDINE MERCK 19-462 SE8 030 28-Aug-00 6-Jun-02   21.3
FAMOTIDINE MERCK 19-510 SE8 028 28-Aug-00 6-Jun-02   21.3
FAMOTIDINE MERCK 19-527 SE8 024 28-Aug-00 6-Jun-02   21.3
FAMOTIDINE MERCK 20-249 SE8 011 28-Aug-00 6-Jun-02   21.3
FAMOTIDINE MERCK 20-752 SE8 005 28-Aug-00 6-Jun-02   21.3
FINASTERIDE MERCK RES 20-788 SE8 007 10-Apr-01 10-Apr-02   12.0
FLUOXETINE HYDROCHLORIDE LILLY 18-936 SE8 065 23-Feb-01 29-Jul-02   17.1
FLUOXETINE HYDROCHLORIDE LILLY 20-101 SE8 027 23-Feb-01 29-Jul-02   17.1
FLUOXETINE HYDROCHLORIDE LILLY 20-974 SE8 001 23-Feb-01 29-Jul-02   17.1
GABAPENTIN PFIZER PHARMS 20-235 SE8 023 16-Jan-02 15-Aug-02   6.9
GABAPENTIN PFIZER PHARMS 20-882 SE8 009 16-Jan-02 15-Aug-02   6.9
GABAPENTIN PARKE DAVIS 21-129 SE8 010 16-Jan-02 15-Aug-02   6.9
GLIPIZIDE PFIZER 20-329 SE8 002 3-Nov-98 1-Apr-02   40.9
INSULIN ASPART [RDNA ORIGIN] NOVO NORDISK PHARM 20-986 SE8 011 11-Mar-02 4-Dec-02   8.8
ISOTRETINOIN HOFFMAN LA-ROCHE 18-662 SE8 043 2-May-01 2-May-02   12.0
LOPINAVIR / RITONAVIR ABBOTT LABS 21-226 SE8 003 20-Mar-01 18-Jan-02   10.0
LOPINAVIR / RITONAVIR ABBOTT LABS 21-226 SE8 004 13-Jul-01 18-Jan-02   6.2
LOPINAVIR / RITONAVIR ABBOTT LABS 21-251 SE8 003 13-Apr-01 18-Jan-02   9.2
LOPINAVIR / RITONAVIR ABBOTT LABS 21-251 SE8 004 13-Jul-01 18-Jan-02   6.2
MIRTAZAPINE ORGANON 20-415 SE8 009 6-Nov-00 9-Apr-02   17.1
OMEPRAZOLE ASTRAZENECA 19-810 SE8 061 28-Jun-99 14-Feb-02   31.6
PAMIDRONATE DISODIUM NOVARTIS PHARM 20-036 SE8 026 22-Apr-02 12-Jul-02   2.7
PAROXETINE HYDROCHLORIDE GLAXOSMITHKLINE 20-031 SE8 035 25-Apr-01 2-Oct-02   17.3
PIOGLITAZONE HYDROCHLORIDE TAKEDA PHARMS 21-073 SE8 010 5-Mar-01 12-Jul-02   16.2
PORACTANT ALFA DEY 20-744 SE8 004 2-May-01 1-Mar-02   10.0
RABEPRAZOLE SODIUM EISAI MEDCL RES 20-973 SE8 013 11-Jan-02 8-Nov-02   9.9
REPAGLINIDE NOVO NORDISK PHARM 20-741 SE8 012 21-Mar-01 18-Jan-02   10.0
RISPERIDONE JANSSEN RES FDN 20-272 SE8 008 12-Mar-97 3-Mar-02   59.7
RISPERIDONE JANSSEN RES FDN 20-588 SE8 004 14-Mar-97 3-Mar-02   59.7
ROFECOXIB MERCK RES 21-042 SE8 007 29-Jun-00 11-Apr-02   21.4
ROFECOXIB MERCK RES 21-052 SE8 004 29-Jun-00 11-Apr-02   21.4
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 19-839 SE8 034 21-May-01 20-Sep-02   16.0
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 19-839 SE8 036 21-May-01 20-Sep-02   16.0
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 20-990 SE8 002 21-May-01 20-Sep-02   16.0
SERTRALINE HYDROCHLORIDE PFIZER PHARMS 20-990 SE8 004 21-May-01 20-Sep-02   16.0
SILDENAFIL CITRATE PFIZER 20-895 SE8 018 19-Nov-01 19-Sep-02   10.0
SIMVASTATIN MERCK 19-766 SE8 052 4-Dec-00 21-Mar-02   15.5
STAVUDINE BRISTOL MYERS SQUIBB 20-412 SE8 016 1-Jun-01 29-Mar-02   9.9
STAVUDINE BRISTOL MYERS SQUIBB 20-413 SE8 007 1-Jun-01 29-Mar-02   9.9
VALSARTAN NOVARTIS PHARMS 21-283 SE8 002 19-Oct-01 5-Apr-02   5.5
VINORELBINE TARTRATE GLAXOSMITHKLINE 20-388 SE8 014 18-Jun-02 5-Nov-02 Y 4.6

 

*Supplement Type Description for SE8
SE8 Incorporate other information based on at least one adequate and well controlled clinical study.