| 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. |
| |
|
|
|
|
|
|
|
|
|
| CEFUROXIME AXETIL |
GLAXO WELLCOME |
50-672 |
09/15/98 |
08/24/99 |
SE8 |
14 |
N |
11.3 |
Treatment of acute bacterial maxillary sinusitis in pediatric patents. |
| |
|
|
|
|
|
|
|
|
|
| POLYMYXIN B SULFATE NEOMYCIN SULFATE HYDROCORTISONE |
MONARCH PHARMS |
50-479 |
03/24/99 |
08/26/99 |
SE8 |
15 |
N |
5.1 |
Treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. |
| |
|
|
|
|
|
|
|
|
|
| ONDANSETRON HYDROCHLORIDE |
GLAXO WELLCOME |
20-103 |
08/28/98 |
08/27/99 |
SE1 |
15 |
N |
12.0 |
Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin. |
| |
|
|
|
|
|
|
|
|
|
| MENOTROPINS |
FERRING PHARMS |
21-047 |
10/28/98 |
08/27/99 |
N |
0 |
N |
10.0 |
For use in conjunction with hCG for multiple follicular development and ovulation induction in patients who have previously received pituitary suppression. |
| |
|
|
|
|
|
|
|
|
|
| BUPROPION HYDROCHLORIDE |
GLAXO WELLCOME |
20-711 |
08/05/97 |
09/10/99 |
SE4 |
1 |
N |
25.2 |
For use as an aid to smoking cessation. |
| |
|
|
|
|
|
|
|
|
|
| BUPROPION HYDROCHLORIDE |
GLAXO WELLCOME |
20-711 |
02/13/98 |
09/10/99 |
SE2 |
3 |
N |
18.9 |
For use as an aid to smoking cessation. |
| |
|
|
|
|
|
|
|
|
|
| NIACIN |
KOS PHARMS |
20-381 |
05/07/99 |
09/13/99 |
SE2 |
7 |
N |
4.2 |
Provides for a change in the dosing titration scheme of Niaspan (niacin extended-release tablets) to the following: - 500 mg qhs for one month, - 1000 mg qhs for one month, - adjust dose to patient response and tolerability, increasing to 1500 mg qhs and 2000 mg qhs if required, but daily dose should not be increased by more than 500 mg in a 4-week period. |
| |
|
|
|
|
|
|
|
|
|
| ZAFIRLUKAST |
ZENECA |
20-547 |
09/18/98 |
09/17/99 |
SE1 |
7 |
N |
12.0 |
Prophylaxis and chronic treatment of asthma in pediatric patients 7-11 years of age. |
| |
|
|
|
|
|
|
|
|
|
| EPTIFIBATIDE |
COR |
20-718 |
10/13/98 |
09/20/99 |
SE8 |
2 |
N |
11.2 |
Treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention. |
| |
|
|
|
|
|
|
|
|
|
| METFORMIN HYDROCHLORIDE |
BRISTOL MYERS SQUIBB |
20-357 |
03/26/99 |
09/22/99 |
SE8 |
17 |
N |
5.9 |
Provides for the deletion of the entire subsection titled "Special Warning on Increased Risk of Cardiovascular Mortality" of the WARNINGS section of the package insert. |
| |
|
|
|
|
|
|
|
|
|
| RALOXIFENE HYDROCHLORIDE |
LILLY |
20-815 |
03/31/99 |
09/30/99 |
SE1 |
3 |
Y |
6.0 |
Treatment of osteoporosis in postmenopausal women. |
| |
|
|
|
|
|
|
|
|
|
| TOPIRAMATE |
JOHNSON RW |
20-505 |
08/01/97 |
10/01/99 |
SE1 |
3 |
N |
26.0 |
Provides for the use of Topamax as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures. |
| |
|
|
|
|
|
|
|
|
|
| TOPIRAMATE |
JOHNSON RW |
20-844 |
04/02/99 |
10/01/99 |
SE1 |
4 |
N |
6.0 |
Provides for the use of Topamax as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures. |
| |
|
|
|
|
|
|
|
|
|
| TROGLITAZONE |
SANKYO |
20-719 |
01/19/99 |
10/01/99 |
SE1 |
12 |
N |
8.4 |
For combination therapy with metformin and sulfonylurea in patients with type 2 diabetes. |
| |
|
|
|
|
|
|
|
|
|
| ACETAMINOPHEN/ ASPIRIN/CAFFEINE |
BRISTOL MYERS |
20-802 |
12/18/98 |
10/07/99 |
SE1 |
2 |
N |
9.6 |
Treatment of Migraine |
| |
|
|
|
|
|
|
|
|
|
| PRAVASTATIN SODIUM |
BRISTOL MYERS SQUIBB |
19-898 |
05/25/99 |
10/14/99 |
SE1 |
34 |
N |
4.7 |
Provides for the addition of the reduction in apolipoprotein B (apo B) to the "Hypercholesterolemia and Mixed Dyslipidemia" subsection of the INDICATIONS AND USAGE section of the Pravachol package insert. |
| |
|
|
|
|
|
|
|
|
|
| REMIFENTANIL HYDROCHLORIDE |
ABBOTT LABS |
20-630 |
12/16/98 |
10/15/99 |
SE5 |
1 |
N |
10.0 |
For use as an analgesic agent during the maintenance of general anesthesia in pediatric patients for inpatient and outpatient surgery. |
| |
|
|
|
|
|
|
|
|
|
| ETHINYL ESTRADIOL /NORETHINDRONE ACETATE |
PARKE DAVIS |
21-102 |
12/17/98 |
10/15/99 |
N |
0 |
N |
9.9 |
For the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis. |
| |
|
|
|
|
|
|
|
|
|
| PACLITAXEL |
BRISTOL MYERS SQUIBB |
20-262 |
04/26/99 |
10/25/99 |
SE1 |
33 |
Y |
6.0 |
Provides for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. |
| |
|
|
|
|
|
|
|
|
|
| NIACIN |
KOS PHARMS |
20-381 |
12/28/98 |
10/28/99 |
SE1 |
6 |
N |
10.0 |
Provides for the addition of the phrase "and to increase HDL-C" to item number one in the list of indications in the INDICATIONS AND USAGE section of the Niaspan package insert. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-154 |
04/30/99 |
10/28/99 |
SE2 |
29 |
Y |
6.0 |
Provides for a new strength of VIDEX tablets (200 mg) as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-155 |
04/30/99 |
10/28/99 |
SE2 |
21 |
Y |
6.0 |
Provides for a new strength of VIDEX tablets (200 mg) as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| DIDANOSINE |
BRISTOL MYERS SQUIBB |
20-156 |
04/30/99 |
10/28/99 |
SE2 |
22 |
Y |
6.0 |
Provides for a new strength of VIDEX tablets (200 mg) as well as allowing a change in dosing interval to once-daily administration, when used in combination therapy for the treatment of HIV-1 infection. |
| |
|
|
|
|
|
|
|
|
|
| RANITIDINE HYDROCHLORIDE |
GLAXO WELLCOME |
18-703 |
12/16/96 |
10/29/99 |
SE8 |
56 |
N |
34.4 |
Provides for labeling revisions regarding use in pediatric patients from 1 month to 16 years of age in response to the Final Rule. |
| |
|
|
|
|
|
|
|
|
|
| CEFDINIR |
PARKE DAVIS |
50-739 |
11/16/98 |
11/08/99 |
SE2 |
2 |
N |
11.7 |
A 5-day dosing regimen (300 mg BID) for the treatment of acute exacerbations of chronic bronchitis. |
| |
|
|
|
|
|
|
|
|
|
| NICOTINE |
NOVARTIS CONS |
20-076 |
12/22/95 |
11/12/99 |
SE6 |
11 |
N |
46.7 |
Provides for the OTC marketing of Habitrol patches to adults (those who are at least 18 years of age) for use as an aid to stop smoking cigarettes. |
| |
|
|
|
|
|
|
|
|
|
| RIZATRIPTAN BENZOATE |
MERCK |
20-864 |
11/08/99 |
11/16/99 |
SE8 |
3 |
N |
0.3 |
Acute treatment of Migraine |
| |
|
|
|
|
|
|
|
|
|
| RIZATRIPTAN BENZOATE |
MERCK |
20-865 |
01/19/99 |
11/16/99 |
SE8 |
1 |
N |
9.9 |
Acute treatment of Migraine |
| |
|
|
|
|
|
|
|
|
|
| SIMVASTATIN |
MERCK |
19-766 |
01/22/99 |
11/22/99 |
SE1 |
34 |
N |
10.0 |
Provides for a new indication for the treatment of patients with isolated hypertriglyceridemia (Frederickson Type IV) . |
| |
|
|
|
|
|
|
|
|
|
| SIMVASTATIN |
MERCK |
19-766 |
01/22/99 |
11/22/99 |
SE1 |
36 |
N |
10.0 |
Provides for a new indication for the treatment of Type III hyperlipoproteinemia . |
| |
|
|
|
|
|
|
|
|
|
| REMIFENTANIL HYDROCHLORIDE |
ABBOTT LABS |
20-630 |
01/29/99 |
11/23/99 |
SE8 |
2 |
N |
9.8 |
Changes in labeling in response to a Phase 4 commitment to provide additional safety and efficacy data in the cardiac surgery setting. |
| |
|
|
|
|
|
|
|
|
|
| ALENDRONATE SODIUM |
MERCK |
20-560 |
01/28/99 |
11/24/99 |
SE8 |
18 |
N |
9.9 |
Provides for the addition to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the labeling safety and efficacy information from two clinical studies in which Fosamax was used concomitantly with estrogen alone or with estrogen plus progestin. |
| |
|
|
|
|
|
|
|
|
|
| ALENDRONATE SODIUM |
MERCK |
20-560 |
09/04/98 |
11/24/99 |
SE8 |
15 |
N |
14.7 |
Provides for the addition to the CLINICAL PHARMACOLOGY section of the labeling the safety and efficacy information for the four-year Fracture Intervention Study. |
| |
|
|
|
|
|
|
|
|
|
| NELFINAVIR MESYLATE |
AGOURON |
20-778 |
01/28/99 |
11/24/99 |
SE2 |
11 |
N |
9.9 |
Provides for a 1250mg twice daily dosing regimen of Viracept in combination with other antiretroviral therapies as an alternate dosing regimen for the standard dosing regimen of 750mg three times daily in combination with other antiretrovirals for the treatment of HIV infection. |
| |
|
|
|
|
|
|
|
|
|
| NELFINAVIR MESYLATE |
AGOURON |
20-779 |
01/28/99 |
11/24/99 |
SE2 |
22 |
N |
9.9 |
Provides for a 1250mg twice daily dosing regimen of Viracept in combination with other antiretroviral therapies as an alternate dosing regimen for the standard dosing regimen of 750mg three times daily in combination with other antiretrovirals for the treatment of HIV infection. |
| |
|
|
|
|
|
|
|
|
|
| SOMATROPIN [rDNA origin] |
GENENTECH INC |
19-676 |
02/01/99 |
12/01/99 |
SE8 |
13 |
N |
10.0 |
Provides for the following additions to the CLINICAL PHARMACOLOGY section of the labeling: (1) improvement in spine bone mineral density observed in childhood-onset adult growth hormone deficient patients; and (2) increases in serum alkaline phosphatase. |
| |
|
|
|
|
|
|
|
|
|
| SOMATROPIN, BIOSYNTHETIC |
GENENTECH INC |
20-522 |
02/01/99 |
12/01/99 |
SE8 |
9 |
N |
10.0 |
Provides for the following additions to the CLINICAL PHARMACOLOGY section of the labeling: (1) improvement in spine bone mineral density observed in childhood-onset adult growth hormone deficient patients; and (2) increases in serum alkaline phosphatase. |
| |
|
|
|
|
|
|
|
|
|
| ATORVASTATIN CALCIUM |
WARNER LAMBERT |
20-702 |
03/04/99 |
12/02/99 |
SE1 |
18 |
N |
9.0 |
Provides for the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb). |
| |
|
|
|
|
|
|
|
|
|
| MOMETASONE FUROATE MONOHYDRATE |
SCHERING PLOUGH |
20-762 |
02/02/99 |
12/02/99 |
SE1 |
4 |
N |
10.0 |
Indicated for the treatment of nasal symptoms of seasonal and perennial rhinitis in adults and children 3 years of age and older. |
| |
|
|
|
|
|
|
|
|
|
| SERTRALINE HYDROCHLORIDE |
PFIZER PHARMS |
19-839 |
10/07/98 |
12/07/99 |
SE1 |
26 |
N |
14.0 |
Provides for the additional indication of treatment of Post-traumatic Stress Disorder. |
| |
|
|
|
|
|
|
|
|
|
| LEVOCARNITINE |
SIGMA TAU |
20-182 |
02/01/99 |
12/15/99 |
SE1 |
6 |
N |
10.4 |
For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. |
| |
|
|
|
|
|
|
|
|
|
| DOCETAXEL |
RHONE POULENC |
20-449 |
06/23/99 |
12/23/99 |
SE1 |
11 |
Y |
6.0 |
Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. |
| |
|
|
|
|
|
|
|
|
|
| CELECOXIB |
SEARLE |
21-156 |
06/25/99 |
12/23/99 |
N |
0 |
Y |
6.0 |
To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). |
| |
|
|
|
|
|
|
|
|
|
| TRAMADOL HYDROCHLORIDE |
JOHNSON RW |
20-281 |
02/26/99 |
12/23/99 |
SE2 |
16 |
N |
9.9 |
Management of moderate to moderately severe pain. |
