| GENERIC NAME |
APPLICANT |
NDA NUMBER |
RECEIPT DATE |
APPROVAL DATE |
SUPP TYPE |
SUPP NUMBER |
PRIOITY REVIEW |
TOTAL APPROVAL TIME (MONTHS) |
INDICATION/DESCRIPTION |
| |
|
|
|
|
|
|
|
|
|
| ATOVAQUONE |
GLAXO WELLCOME |
20-500 |
03/06/98 |
01/05/99 |
SE1 |
5 |
N |
10.0 |
Prevention of Pneumocystis carinii pneumonia (PCP). |
| |
|
|
|
|
|
|
|
|
|
| TERBINAFINE HYDROCHLORIDE |
NOVARTIS PHARMS |
20-539 |
12/20/96 |
01/05/99 |
SE8 |
3 |
X |
24.5 |
Expansion of labeling to include patients with onychomycosis of fingernail or toenail even when associated with non-dermatophytes. |
| |
|
|
|
|
|
|
|
|
|
| NICOTINE |
NOVARTIS |
20-076 |
02/03/98 |
01/07/99 |
SE4 |
13 |
N |
11.1 |
Relief of nicotine withdrawal symptoms. |
| |
|
|
|
|
|
|
|
|
|
| AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLE |
TAP HOLDINGS |
50-757 |
10/06/98 |
01/22/99 |
SE2 |
2 |
N |
3.6 |
Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence. |
| |
|
|
|
|
|
|
|
|
|
| LEUPROLIDE ACETATE |
TAP HOLDINGS |
20-708 |
04/13/98 |
02/11/99 |
SE8 |
5 |
N |
10.0 |
Comparability demonstrated between 3.75 mg and 11.25 mg depot in the treatment of endometriosis and uterine fibroids. |
| |
|
|
|
|
|
|
|
|
|
| GLIMEPIRIDE |
HOECHST MARION RSSL |
20-496 |
11/04/97 |
02/24/99 |
SE1 |
2 |
N |
15.7 |
Concomitant use with metformin when diet, exercise, and Amaryl alone do not result in adequate glycemic control. |
| |
|
|
|
|
|
|
|
|
|
| FLUNISOLIDE |
DURA |
18-148 |
04/07/89 |
02/25/99 |
SE2 |
23 |
|
118.7 |
Treatment of the nasal symptoms of seasonal and perennial rhinitis. |
| |
|
|
|
|
|
|
|
|
|
| ESTRADIOL |
BERLEX LABS |
20-994 |
05/05/98 |
03/05/99 |
N |
0 |
N |
10.0 |
Prevention of postmenopausal osteoporosis for the previously approved strengths (0.05 mg/day, 0.075 mg/day and 0.1 mg/day) and a new lower strength of 0.025 mg/day. |
| |
|
|
|
|
|
|
|
|
|
| FLUVASTATIN SODIUM |
NOVARTIS PHARM |
20-261 |
07/22/98 |
03/08/99 |
SE1 |
18 |
N |
7.5 |
Reduction of triglycerides and ApoB in patients with primary hypercholestrolemia and mixed dyslipidemia. |
| |
|
|
|
|
|
|
|
|
|
| FLUVASTATIN SODIUM |
NOVARTIS PHARM |
20-261 |
07/22/98 |
03/08/99 |
SE8 |
22 |
N |
7.5 |
Provides for a reduction in the recommended frequency of Liver Function Testing (LFT) and eliminates semi-annual LFT monitoring. |
| |
|
|
|
|
|
|
|
|
|
| RANITIDINE HYDROCHLORIDE |
GLAXO WELLCOME |
20-745 |
05/13/98 |
03/08/99 |
SE1 |
1 |
N |
9.8 |
Prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages. |
| |
|
|
|
|
|
|
|
|
|
| CIDOFOVIR |
GILEAD |
20-638 |
03/09/98 |
03/09/99 |
SE8 |
3 |
N |
12.0 |
Provides for the use of Vistide (cidofovir injection) 75 mg/mL for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. |
| |
|
|
|
|
|
|
|
|
|
| TERBINAFINE HYDROCHLORIDE |
NOVARTIS |
20-980 |
03/30/98 |
03/09/99 |
N |
0 |
N |
11.3 |
Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm). |
| |
|
|
|
|
|
|
|
|
|
| LOVASTATIN |
MERCK |
19-643 |
04/29/98 |
03/11/99 |
SE1 |
55 |
N |
10.4 |
Primary prevention of coronary heart disease in patients without symptomatic cardiovascular disease who have average to moderately elevated total-C and LDL-C and below average HDL-C. |
| |
|
|
|
|
|
|
|
|
|
| LIDOCAINE PRILOCAINE |
ASTRA PHARMS |
19-941 |
05/15/98 |
03/11/99 |
SE8 |
10 |
N |
9.9 |
Expands the pediatric indication to children younger than one month of age to birth (with a gestational age of 37 weeks or greater) |
| |
|
|
|
|
|
|
|
|
|
| VENLAFAXINE HYDROCHLORIDE |
WYETH AYERST LABS |
20-699 |
01/30/98 |
03/11/99 |
SE1 |
1 |
N |
13.3 |
Treatment of generalized anxiety disorder as a new indication. |
| |
|
|
|
|
|
|
|
|
|
| LAMIVUDINE |
GLAXO WELLCOME |
20-564 |
03/30/98 |
03/23/99 |
SE8 |
7 |
N |
11.8 |
Provides for the inclusion of additional pediatric information into the labeling. |
| |
|
|
|
|
|
|
|
|
|
| LAMIVUDINE |
GLAXO WELLCOME |
20-596 |
03/30/98 |
03/23/99 |
SE8 |
7 |
N |
11.8 |
Provides for the inclusion of additional pediatric information into the labeling. |
| |
|
|
|
|
|
|
|
|
|
| DALTEPARIN SODIUM |
PHARMACIA AND UPJOHN |
20-287 |
04/17/97 |
03/30/99 |
SE1 |
8 |
N |
23.4 |
Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism, in patients undergoing hip replacement surgery. |
| |
|
|
|
|
|
|
|
|
|
| IBUPROFEN |
MCNEIL CONS PRODS |
20-603 |
06/15/98 |
04/15/99 |
SE5 |
3 |
N |
10.0 |
Provides for dosing for ages 6 months to 2 years. |
| |
|
|
|
|
|
|
|
|
|
| MUPIROCIN |
SMITHKLINE BEECHAM |
50-591 |
04/27/98 |
04/22/99 |
SE8 |
22 |
N |
11.8 |
"Pediatric Use" subsection added to labeling. |
| |
|
|
|
|
|
|
|
|
|
| ISOPROTERENOL HYDROCHLORIDE |
ABBOTT LABS |
10-515 |
01/05/98 |
05/04/99 |
SE1 |
22 |
N |
15.9 |
"Pediatric Use" subsection added to labeling. |
| |
|
|
|
|
|
|
|
|
|
| PAROXETINE HYDROCHLORIDE |
SKB PHARMS |
20-031 |
05/06/98 |
05/11/99 |
SE1 |
23 |
N |
12.2 |
Treatment of social anxiety disorder. |
| |
|
|
|
|
|
|
|
|
|
| IBUTILIDE FUMARATE |
PHARMACIA AND UPJOHN |
20-491 |
12/22/97 |
05/13/99 |
SE8 |
1 |
N |
16.7 |
Provides for additions to the labeling regarding post-cardiac surgery patients. |
| |
|
|
|
|
|
|
|
|
|
| CERIVASTATIN |
BAYER |
20-740 |
07/17/98 |
05/24/99 |
SE2 |
2 |
N |
10.2 |
Provides for a new 0.4 mg dosage strength. |
| |
|
|
|
|
|
|
|
|
|
| DALTEPARIN SODIUM |
PHARMACIA AND UPJOHN |
20-287 |
06/01/98 |
05/25/99 |
SE1 |
10 |
N |
11.8 |
Treatment of unstable angina and non-Q-wave myocardial infarction and for the prevention of ischemic complications in patients on concurrent aspirin therapy. |
| |
|
|
|
|
|
|
|
|
|
| RITONAVIR |
ABBOTT LABS |
20-659 |
05/26/98 |
05/26/99 |
SE7 |
13 |
N |
12.0 |
For the treatment of HIV infection in combination with other antiretroviral agents. |
| |
|
|
|
|
|
|
|
|
|
| RITONAVIR |
ABBOTT LABS |
20-680 |
05/26/98 |
05/26/99 |
SE7 |
11 |
N |
12.0 |
For the treatment of HIV infection in combination with other antiretroviral agents. |
| |
|
|
|
|
|
|
|
|
|
| ETODOLAC |
WYETH AYERST LABS |
20-584 |
11/12/97 |
05/27/99 |
SE2 |
3 |
N |
18.4 |
Provides for the increase in the maximum daily dose to 1200 mg/day for the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis. |
| |
|
|
|
|
|
|
|
|
|
| ALBUTEROL SULFATE |
3M PHARMACEUTICALS |
20-503 |
06/02/98 |
06/02/99 |
SE1 |
11 |
N |
12.0 |
Provides for lowering the age from 12 years to 4 years and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. |
| |
|
|
|
|
|
|
|
|
|
| ALENDRONATE SODIUM |
MERCK |
20-560 |
06/08/98 |
06/08/99 |
SE8 |
13 |
N |
12.0 |
Provides for the extension of the use of the drug from three to five years for the treatment of postmenopausal osteoporosis. |
| |
|
|
|
|
|
|
|
|
|
| ALENDRONATE SODIUM |
MERCK |
20-560 |
11/26/97 |
06/16/99 |
SE1 |
12 |
N |
18.6 |
Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density. |
| |
|
|
|
|
|
|
|
|
|
| TROGLITAZONE |
PARKE DAVIS PHARMS |
20-720 |
11/19/98 |
06/16/99 |
SE1 |
12 |
N |
6.9 |
Provides for the use in combination with metformin and sulfonylurea in patients with type 2 diabetes. |
| |
|
|
|
|
|
|
|
|
|
| FLUTICASONE PROPIONATE |
GLAXO WELLCOME |
19-958 |
06/09/95 |
06/17/99 |
SE5 |
8 |
N |
48.3 |
Provides for the use in pediatric patients 3 months of age or older with corticosteroid-responsive dermatoses. |
| |
|
|
|
|
|
|
|
|
|
| AMIFOSTINE |
US BIOSCIENCE |
20-221 |
12/24/98 |
06/24/99 |
SE1 |
12 |
Y |
6.0 |
To reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. |
| |
|
|
|
|
|
|
|
|
|
| DOXORUBICIN HYDROCHLORIDE |
ALZA |
50-718 |
12/29/98 |
06/28/99 |
SE1 |
6 |
Y |
6.0 |
Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-154 |
07/01/98 |
07/01/99 |
SE1 |
28 |
N |
12.0 |
Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-155 |
07/01/98 |
07/01/99 |
SE1 |
20 |
N |
12.0 |
Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-156 |
07/01/98 |
07/01/99 |
SE1 |
21 |
N |
12.0 |
Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| STAVUDINE |
BRISTOL MYERS SQUIBB |
20-412 |
07/01/98 |
07/01/99 |
SE1 |
10 |
N |
12.0 |
Expands the monotherapy indication to provide for the use of Zerit in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| STAVUDINE |
BRISTOL MYERS SQUIBB |
20-413 |
07/01/98 |
07/01/99 |
SE1 |
3 |
N |
12.0 |
Expands the monotherapy indication to provide for the use of Zerit in combination with other antiretroviral agents for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| LANSOPRAZOLE |
TAP HOLDINGS |
20-406 |
04/16/98 |
07/06/99 |
SE4 |
28 |
N |
14.7 |
Day and night heartburn. |
| |
|
|
|
|
|
|
|
|
|
| CALCIPOTRIENE |
WESTWOOD SQUIBB |
20-273 |
07/08/98 |
07/07/99 |
SE8 |
4 |
N |
12.0 |
Treatment of plaque psoriasis in adults |
| |
|
|
|
|
|
|
|
|
|
| CEFDINIR |
PARKE DAVIS |
50-749 |
07/15/98 |
07/14/99 |
SE2 |
2 |
N |
12.0 |
5-day dosing regimen (7mg/kg BID) for the treatment of acute otitis media (10-day regimen previously approved). |
| |
|
|
|
|
|
|
|
|
|
| TOPIRAMATE |
JOHNSON RW |
20-505 |
08/01/97 |
07/23/99 |
SE1 |
1 |
N |
23.7 |
Use as adjunctive therapy in pediatric patients ages 2-16 years with partial onset seizures. |
| |
|
|
|
|
|
|
|
|
|
| TOPIRAMATE |
JOHNSON RW |
20-844 |
02/01/99 |
07/23/99 |
SE1 |
1 |
N |
5.7 |
Use as adjunctive therapy in pediatric patients ages 2-16 years with partial onset seizures. |
| |
|
|
|
|
|
|
|
|
|
| TERBINAFINE |
NOVARTIS PHARMS |
20-846 |
10/23/98 |
07/26/99 |
SE1 |
1 |
N |
9.1 |
Tinea cruris. |
| |
|
|
|
|
|
|
|
|
|
| GRANISETRON HYDROCHLORIDE |
SKB PHARMS |
20-305 |
07/27/98 |
07/27/99 |
SE1 |
4 |
N |
12.0 |
Prevention of nausea and vomiting associated with radiation, including total body irradiation (TBI) and fractionated abdominal radiation. |
| |
|
|
|
|
|
|
|
|
|
| SIMVASTATIN |
MERCK |
19-766 |
10/19/98 |
08/05/99 |
SE1 |
32 |
N |
9.5 |
For the additional indication of increasing HDL-C in patients with primary hypercholestrolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). |
| |
|
|
|
|
|
|
|
|
|
| ACARBOSE |
BAYER |
20-482 |
08/17/98 |
08/16/99 |
SE8 |
10 |
N |
12.0 |
Management of type 2 diabetes mellitus. |
| |
|
|
|
|
|
|
|
|
|
| MIGLITOL |
PHARMACIA AND UPJOHN |
20-682 |
08/19/98 |
08/16/99 |
SE8 |
1 |
N |
11.9 |
For use in the management of non-insulin-dependent diabetes mellitus (NIDDM). |
| |
|
|
|
|
|
|
|
|
|
| FLUOCINOLONE ACETONIDE |
HILL DERM |
19-452 |
08/18/98 |
08/18/99 |
SE1 |
15 |
N |
12.0 |
Treatment of atopic dermatitis in pediatric patients 6 years of age or older. |
| |
|
|
|
|
|
|
|
|
|
| CEFUROXIME AXETIL |
GLAXO WELLCOME |
50-605 |
09/15/98 |
08/24/99 |
SE8 |
32 |
N |
11.3 |
Treatment of acute bacterial maxillary sinusitis in pediatric patents. |
| |
|
|
|
|
|
|
|
|
|
