| GENERIC NAME |
APPLICANT |
NDA NUMBER |
RECEIPT DATE |
APPROVAL DATE |
SUPP TYPE |
SUPP NUMBER |
PRIORITY
REVIEW |
TOTAL APPROVAL TIME (MONTHS) |
INDICATION/DESCRIPTION |
| 13C-UREA |
MERETEK |
20-586 |
10-Jul-00 |
10-May-01 |
SE2 |
004 |
N |
10.0 |
Provides for a decrease in dose of 13C-urea from 125 mg to 75 mg in the BreathTekTM UBT Collection Kit. |
| ALENDRONATE SODIUM |
MERCK |
20-560 |
31-Mar-00 |
31-Jan-01 |
SE2 |
025 |
N |
10.1 |
Provides for the consideration of using Fosamax 70 mg in men once weekly for the treatment to increase bone mass in men with osteoporosis. |
| AMPRENAVIR |
GLAXO WELLCOME |
21-007 |
14-Jul-00 |
11-May-01 |
SE7 |
006 |
N |
9.9 |
Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| AMPRENAVIR |
GLAXO WELLCOME |
21-039 |
14-Jul-00 |
11-May-01 |
SE7 |
006 |
N |
9.9 |
Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| AZITHROMYCIN |
PFIZER |
50-710 |
16-Feb-01 |
14-Dec-01 |
SE2 |
008 |
N |
9.9 |
Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 1-day dosing regimen. |
| AZITHROMYCIN |
PFIZER |
50-710 |
16-Feb-01 |
14-Dec-01 |
SE2 |
009 |
N |
9.9 |
Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 3-day dosing regimen. |
| BETAMETHASONE DIPROPIONATE |
SCHERING |
17-536 |
5-Oct-00 |
3-Oct-01 |
SE5 |
024 |
X |
11.9 |
Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Cream, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-018. |
| BETAMETHASONE DIPROPIONATE |
SCHERING |
17-691 |
5-Oct-00 |
3-Oct-01 |
SE5 |
024 |
X |
11.9 |
Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Ointment, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-019. |
| BETAMETHASONE DIPROPIONATE |
SCHERING |
17-781 |
5-Oct-00 |
3-Oct-01 |
SE5 |
022 |
X |
11.9 |
Provides for labeling revisions. Specifically, S-022 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Lotion, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-015. |
| BETAMETHASONE DIPROPIONATE |
SCHERING |
19-555 |
5-Oct-00 |
3-Oct-01 |
SE5 |
016 |
X |
11.9 |
Provides for labeling revisions. Specifically, S-016 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROLENE AF Cream in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-008. |
| BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION |
ALLERGAN |
20-490 |
15-Aug-01 |
20-Dec-01 |
SE5 |
007 |
N |
4.2 |
Proposes a change in the wording of the pediatric section of the package inserts. |
| BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION |
ALLERGAN |
20-613 |
15-Aug-01 |
20-Dec-01 |
SE5 |
018 |
N |
4.2 |
Proposes a change in the wording of the pediatric section of the package inserts. |
| BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION |
ALLERGAN |
21-262 |
15-Aug-01 |
20-Dec-01 |
SE5 |
006 |
N |
4.2 |
Proposes a change in the wording of the pediatric section of the package inserts. |
| BUSPIRONE HCL |
BRISTOL MYERS SQUIBB |
18-731 |
21-Mar-00 |
19-Jul-01 |
SE5 |
043 |
N |
15.9 |
Provides for new language for pediatric use. |
| BUTENAFINE HCL |
BERTEK PHARMS |
20-524 |
7-Aug-00 |
6-Jun-01 |
SE1 |
005 |
N |
10.0 |
Provides for the use of Mentax (butenafine HCl cream) Cream, 1%, for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare). |
| BUTENAFINE HYDROCHLORIDE |
SCHERING PLOUGH |
21-307 |
29-Sep-00 |
7-Dec-01 |
N |
000 |
N |
14.3 |
Provides for the use without prescription of Lotrimin Ultra butenafine hydrochloride cream 1%, for the topical treatment of the following superficial dermatophytoses: interdigital tinea pedis (athlete's foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans. |
| CAPCITABINE |
HLR |
20-896 |
8-Mar-01 |
7-Sep-01 |
SE7 |
010 |
Y |
6.0 |
Provides for the use of Xeloda (capcitabine) Tablets in combination with Taxotere (docetaxel) for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. |
| CAPECITABINE |
HLR |
20-896 |
20-Sep-99 |
30-Apr-01 |
SE1 |
006 |
N |
19.3 |
Provides for the use of XELOD as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. |
| CARVEDILOL |
GLAXO SMITH KLINE |
20-297 |
2-Mar-01 |
1-Nov-01 |
SE1 |
007 |
N |
8.0 |
Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets for severe heart failure. |
| CELECOXIB CAPSULE |
SEARLE |
20-998 |
19-Dec-00 |
18-Oct-01 |
SE1 |
010 |
N |
10.0 |
Provides for the use of Celebrex (celecoxib capsule) Capsules 100 mg, and 200 mg for the management of acute pain in adults and the treatment of primary dysmenorrhea. |
| CLARITHROMYCIN EXTENDED RELEASE TABLETS |
ABBOTT LABS |
50-775 |
2-Oct-00 |
2-Aug-01 |
SE1 |
001 |
N |
10.0 |
Provides for addition of Community-Acquired Pneumonia due to Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Chlamydia pneumonia (TWAR), Legionella pneumophila or Mycoplasma Pneumoniae to the BIAXIN XL Filmtab label. |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE |
SCHERING |
18-827 |
5-Oct-00 |
3-Oct-01 |
SE5 |
022 |
X |
11.9 |
Provides final pediatric study reports and a safety update in response to the Pediatric Written Request and supersedes S-007, S-009, and S-020. |
| CROMOLYN SODIUM NASAL SOLUTION |
PHARMACIA UPJOHN |
20-463 |
31-Aug-99 |
27-Mar-01 |
SE5 |
002 |
N |
18.9 |
Provides for the use of NasalCrom Nasal Solution (cromolyn sodium nasal solution) nasal spray for use in children down to 2 years of age. |
| DELAVIRDINE MESYLATE |
AGOURON |
20-705 |
17-Jul-00 |
16-May-01 |
SE7 |
008 |
N |
10.0 |
Provides for the use of RESCRIPTOR for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted. |
| DOPAMINE HCL AND 5% DEXTROSE INJECTION IN PLASTIC CONTAINER |
BAXTER HLTHCARE |
19-615 |
24-Jun-99 |
17-Apr-01 |
SE5 |
012 |
N |
21.8 |
Provides for final printed labeling revised as follows: Changes in the PRECAUTIONS, Pediatric Use subsection and the addition of a new Pediatric Dosing and Administration subsection under DOSAGE and ADMINISTRATION. |
| EPTIFIBATIDE |
COR |
20-718 |
30-Jun-00 |
8-Jun-01 |
SE2 |
010 |
N |
11.3 |
Provides for labeling revised to reflect the findings of the ESPRIT ("Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (the 'ESPRIT Study); A Phase III Study in Patients Undergoing Percutaneous Coronary Intervention with Stent Implantation") study. The revisions include a new dosing recommendation for patients undergoing Percutaneous Coronary Intervention (PCI) and a revised recommended target range for the activated clotting time (ACT) during PCI. |
| ESOMEPRAZOLE MAGNESIUM |
ASTRAZENECA |
21-154 |
28-Feb-00 |
20-Feb-01 |
N |
000 |
N |
11.8 |
Provides for the use of Nexium (esomeprazole magnesium) Delayed-Release Capsules in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease. |
| ESTRADIOL TRANSDERMAL SYSTEM |
BERLEX LABS |
20-375 |
5-Jun-00 |
5-Apr-01 |
SE1 |
016 |
N |
10.0 |
Provides for the use of the 0.025 mg/day Climara (Estradiol transdermal System) for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause. |
| FLUOCINOLONE ACETONIDE |
HILL DERM |
19-452 |
10-Oct-00 |
10-Oct-01 |
SE5 |
017 |
N |
12.0 |
Provides for the use of Derma-Smoothe/FS in pediatric patients 2 years and older for the treatment of atopic dermatitis. |
| GATIFLOXACIN |
BRISTOL MYERS SQUIBB |
21-061 |
21-Dec-00 |
12-Oct-01 |
SE2 |
007 |
N |
9.7 |
Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration. |
| GATIFLOXACIN |
BRISTOL MYERS SQUIBB |
21-062 |
3-Jan-01 |
12-Oct-01 |
SE2 |
008 |
N |
9.3 |
Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration. |
| INSULIN ASPART [rDNA ORIGIN] INJECTION |
NOVO NORDISK PHARM |
20-986 |
21-Dec-00 |
21-Dec-01 |
SE3 |
003 |
N |
12.0 |
Provides for the use of NovoLog with the following external insulin pumps: 1. Disertronic H-TRON plus V100 with Disertronic 3.15 plastic cartridges and Classic or Tender infusion sets, or 2. MiniMed Models 505, 506, or 507 with Minimed 3 mL syringes and Polyfin or Sof-set infusion sets. |
| IRBESARTAN |
SANOFI SYNTHELABO |
20-757 |
17-Feb-00 |
26-May-01 |
SE5 |
014 |
N |
15.3 |
Provides for final printed labeling revised as follows: Under CLINICAL PHARMACOLOGY, the Special Populations, the Pediatric subsection has been changed. Under PRECAUTIONS, Pediatric Use, a second paragraph has been added. Under DOSAGE and ADMINISTRATION, a Pediatric Patients subsection has been added. Under HOW SUPPLIED, the 75 mg Blister Pack of 100 (NDC# 0087-2771-35) has been removed. |
| ITRACONAZOLE |
JANSSEN |
20-657 |
1-May-00 |
9-May-01 |
SE1 |
005 |
N |
12.3 |
Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN). |
| ITRACONAZOLE |
JANSSEN |
20-966 |
1-May-00 |
9-May-01 |
SE1 |
004 |
N |
12.3 |
Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN). |
| LAMIVUDINE |
GLAXO WELLCOME |
21-003 |
28-Feb-01 |
16-Aug-01 |
SE1 |
002 |
N |
5.6 |
Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years. |
| LAMIVUDINE |
GLAXO WELLCOME |
21-004 |
28-Feb-01 |
16-Aug-01 |
SE1 |
002 |
N |
5.6 |
Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years. |
| LETROZOLE |
NOVARTIS PHARMS |
20-726 |
12-Jul-00 |
10-Jan-01 |
SE1 |
006 |
Y |
6.0 |
Provides for the use of Femara for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION |
TAP PHARM |
20-011 |
22-Nov-00 |
21-Sep-01 |
SE1 |
021 |
N |
10.0 |
Provides for the use of Lupron Depot 3.75 mg monthly with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months. |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION |
TAP PHARM |
20-708 |
22-Nov-00 |
21-Sep-01 |
SE1 |
011 |
N |
10.0 |
Provides for the use of Lupron Depot-3 Month 11.25 mg with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months. |
| METOPROLOL SUCCINATE |
ASTRAZENECA |
19-962 |
10-Sep-99 |
5-Feb-01 |
SE1 |
013 |
N |
16.9 |
Provides for the new use of Toprol-XL (metoprolol succinate) Tablets for the treatment of congestive heart failure and for a 25 mg dosage strength scored tablet. |
| MICONAZOLE NITRATE 1200 MG SOFT GEL VAGINAL INSERT AND MICONAZOLE NITRATE CREAM, 2% |
PERSONAL PRODS |
21-308 |
1-Sep-00 |
29-Jun-01 |
N |
000 |
N |
9.9 |
Provides for the use of MONISTAT 1 COMBINATION PACK for the treatment of vulvovaginal candidiasis. |
| MOXIFLOXACIN HCL |
BAYER |
21-334 |
10-Dec-98 |
27-Apr-01 |
N |
000 |
N |
28.6 |
Provides for the use of Avelox for the treatment of uncomplicated skin and skin structure infections. |
| NORETHINDRONE ACETATE, 1MG, AND ETHINYL ESTRADIOL, 35MCG |
PARKE DAVIS |
21-276 |
3-Jul-00 |
1-Jul-01 |
N |
000 |
N |
11.9 |
Provides for the use of ESTROSTEP 21 and ESTROSTEP Fe Tablets for the treatment of moderate acne vulgaris in females, >15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. |
| PAMIDRONATE DISODIUM INJECTION |
NOVARTIS PHARM |
20-036 |
13-Aug-01 |
20-Aug-01 |
SE2 |
024 |
N |
0.2 |
Proposes to change the administration rate for the infusion of Aredia from 24 hours to 2 to 24 hours. This change applies to the indication for the treatment of moderate and severe hypercalcemia of malignancy, with or without bone metastases. |
| PANTOPRAZOLE SODIUM |
WYETH AYERST LABS |
20-987 |
12-Jun-00 |
12-Jun-01 |
SE1 |
001 |
N |
12.0 |
Proposes the use of PROTONIX (pantoprazole sodium) Delayed-Release Tablets for the following new indication: Maintenance of Healing of Erosive Esophagitis and control of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD). |
| PANTOPRAZOLE SODIUM |
WYETH AYERST LABS |
20-988 |
20-Apr-01 |
19-Oct-01 |
SE1 |
003 |
Y |
6.0 |
Provides for the use of Protonix I.V. for Injection in the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES). |
| PAROXETINE HCL |
SKB PHARMS |
20-031 |
28-Apr-00 |
13-Apr-01 |
SE1 |
026 |
N |
11.5 |
Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of generalized anxiety disorder as a new indication. |
| PAROXETINE HYDROCHLORIDE |
SKB PHARMS |
20-031 |
21-Jul-00 |
14-Dec-01 |
SE1 |
029 |
N |
16.8 |
Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of posttraumatic stress disorder as a new indication. |
| PRAVASTATIN SODIUM |
BRISTOL MYERS SQUIBB |
19-898 |
1-Mar-01 |
18-Dec-01 |
SE2 |
046 |
N |
9.6 |
Provides for the use of a new dosage strength (80 mg) and dosing regimen (80 mg once per day) of Pravachol (pravastatin sodium) tablets. |
| PROPOFOL |
ASTRAZENECA UK |
19-627 |
21-May-99 |
23-Feb-01 |
SE5 |
035 |
N |
21.2 |
Provides for the use of Diprivan (propofol) Injectable Emulsion in patients 3 months to 16 years old for general anesthesia. |
| SIBUTRAMINE HCL MONOHYDRATE |
KNOLL PHARM |
20-632 |
18-Apr-00 |
16-Feb-01 |
SE2 |
011 |
N |
10.0 |
Provides for an addition to the CLINICAL STUDIES and the DOSAGE AND ADMINISTRATION sections of the labeling indicating the maintenance of weight loss over an 18 month period thus extending the use of this drug from 1 year to 2 years. |
| SOMATROPIN [rDNA origin] FOR INJECTION |
PHARMACIA AND UPJOHN |
20-280 |
3-Jul-00 |
25-Jul-01 |
SE1 |
031 |
Y |
12.7 |
Provides for the use of Genotropin (somatropin [rDNA origin] for injection) for long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age. |
| TAZAROTENE |
ALLERGAN |
21-184 |
11-Dec-00 |
11-Oct-01 |
SE1 |
001 |
N |
10.0 |
Provides for the use of Tazorac (tazarotene) Cream, 0.1% for acne vulgaris. |
| TICLOPIDINE HCL |
SYNTEX (USA) LLC |
19-979 |
24-Jan-00 |
18-Apr-01 |
SE1 |
018 |
N |
14.8 |
Provides for the new use of Ticlid (ticlopidine hydrochloride) Tablets as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation. |
| TOPIRAMATE |
JOHNSON RW |
20-505 |
1-Aug-97 |
28-Aug-01 |
SE1 |
002 |
N |
48.9 |
Provides for the use of Topamax (topiramate) Tablets as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome. |
| TOPIRAMATE |
JOHNSON RW |
20-844 |
8-Jun-01 |
28-Aug-01 |
SE1 |
010 |
N |
2.7 |
Provides for the use of Topamax (topiramate) Sprinkle Capsule as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome. |
| TRIMETHOBENZAMIDE HYDROCHLORIDE |
KING PHARMS |
17-531 |
14-Feb-01 |
13-Dec-01 |
SE2 |
010 |
N |
9.9 |
Provides for the following in response to the Federal Register notice of January 9, 1979, classifying this drug effective for postoperative nausea and vomiting and nausea associated with gastroenteritis: draft labeling, results of bioavailability studies, and updated manufacturing and controls and testing procedures. |
| VALACYCLOVIR HCL |
GLAXO WELLCOME |
20-550 |
31-Aug-00 |
25-Jun-01 |
SE2 |
012 |
N |
9.8 |
Provides for a labeling indication for a shorter treatment course of three days in the treatment of recurrent episodes of genital herpes. |
| VENLAFAXINE HCL |
WYETH AYERST LABS |
20-151 |
19-May-00 |
2-May-01 |
SE1 |
017 |
N |
11.4 |
Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression. |
| VENLAFAXINE HCL |
WYETH AYERST LABS |
20-151 |
22-May-00 |
2-May-01 |
SE1 |
018 |
N |
11.3 |
Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression. |
| VENLAFAXINE HCL |
WYETH AYERST LABS |
20-699 |
5-May-00 |
2-May-01 |
SE1 |
015 |
N |
11.9 |
Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression. |
| VENLAFAXINE HCL |
WYETH AYERST LABS |
20-699 |
22-May-00 |
2-May-01 |
SE1 |
016 |
N |
11.3 |
Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression. |
| VERTEPORFIN FOR INJECTION |
QLT |
21-119 |
14-Aug-00 |
22-Aug-01 |
SE1 |
001 |
Y |
12.3 |
Provides for the use of Visudyne (verteporfin for injection) therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia. |
| ZAFIRLUKAST |
ASTRAZENECA |
20-547 |
30-Jun-00 |
27-Apr-01 |
SE1 |
014 |
N |
9.9 |
Provides for the use of Accolate 10mg for the prophylaxis and chronic treatment of asthma in pediatric patients 5 - 6 years of age. |
