| 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 |
|
