| GENERIC NAME |
APPLICANT |
NDA NUMBER |
RECEIPT DATE |
APPROVAL DATE |
SUPPLEMENT TYPE |
TOTAL APPROVAL TIME (MONTHS) |
INDICATION/DESCRIPTION |
|
|
|
|
|
|
|
|
| ACARBOSE |
BAYER |
20-482 |
30-Sep-97 |
29-Sep-98 |
SE1 |
12.0 |
For patients with type 2 diabetes treated with diet plus insulin. |
| ACARBOSE |
BAYER |
20-482 |
25-Nov-97 |
29-Sep-98 |
SE1 |
10.1 |
For patients with type 2 diabetes treated with diet plus metformin. |
| ACYCLOVIR SODIUM |
GLAXO WELCOME |
18-603 |
02-Jun-97 |
02-Jun-98 |
SE1 |
12.0 |
Treatment of herpes simplex virus infections in neonatal patients. |
| ALBUTEROL SULFATE |
3M PHARMACEUTICALS |
20-503 |
26-Sep-97 |
23-Sep-98 |
SE1 |
11.9 |
Prevention of exercise-induced bronchospasm in patients 12 years of age and older. |
| AMOXICILLIN |
SMITHKLINE BEECHAM |
50-542 |
06-Oct-97 |
27-Feb-98 |
SE1 |
4.7 |
For use in combination with lansoprazole (with or without clarithromycin) in patients with duodenal ulcer (defined as an active ulcer or history of an ulcer within one year) to eradicate Helicobacter pylori and reduce the risk of duodenal ulcer recurrence. |
| ANAGRELIDE HYDROCHLORIDE |
ROBERTS LABS |
20-333 |
02-Jan-98 |
16-Dec-98 |
SE1 |
11.4 |
Treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. |
| ANASTROZOLE |
ZENECA PHARMS |
20-541 |
10-Feb-97 |
06-Feb-98 |
SLR |
11.9 |
Treatment of advanced breast cancer in postmenopausal women who have progressed following tamoxifen therapy. |
| APROTININ |
BAYER |
20-304 |
06-Nov-96 |
28-Aug-98 |
SE1 |
21.7 |
Prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. |
| ATORVASTATIN CALCIUM |
WARNER LAMBERT |
20-702 |
17-Jul-97 |
10-Jul-98 |
SE1 |
11.8 |
Adjunctive therapy to diet for the treatment of patients with elevated serum primary triglyceride levels (Frederickson Type IV). |
| ATORVASTATIN CALCIUM |
WARNER LAMBERT |
20-702 |
23-Jul-97 |
10-Jul-98 |
SE1 |
11.6 |
Use by patients with primary dysbetalipoproteinemia (Frederickson Type III) who do not respond adequately to diet. |
| AZTREONAM |
BRISTOL MYERS SQUIBB |
50-632 |
29-Dec-97 |
24-Dec-98 |
SE1 |
11.8 |
Pediatric use statement added to labeling for treatment of infections caused by susceptible gram-negative microorganisms. |
| BUDESONIDE |
ASTRA PHARMS |
20-441 |
08-Oct-97 |
08-Oct-98 |
SE2 |
12.0 |
Once daily dosing for maintenance therapy of mild to moderate asthma and for initiation of therapy. |
| CALCITRIOL |
ROCHE |
18-044 |
20-Nov-97 |
20-Nov-98 |
SE1 |
12.0 |
Treatment of secondary hyperparathyroidism in patients (including pediatric patients) with moderate to severe chronic renal failure who are not yet undergoing dialysis. |
| CEFEPIME HYDROCHLORIDE |
BRISTOL MYERS SQUIBB |
50-679 |
31-Jan-97 |
30-Jan-98 |
SE1 |
12.0 |
Additional use in combination with metronidazole for the treatment of complicated intra-abdominal infections. |
| CEFPODOXIME PROXETIL |
PHARMACIA AND UPJOHN |
50-674 |
22-Jan-98 |
20-Nov-98 |
SE1 |
9.9 |
Treatment of acute maxillary sinusitis. |
| CEFPODOXIME PROXETIL |
PHARMACIA AND UPJOHN |
50-675 |
22-Dec-97 |
20-Nov-98 |
SE2 |
10.9 |
5-day treatment of otitis media in pediatric patients. |
| CEFPODOXIME PROXETIL |
PHARMACIA AND UPJOHN |
50-675 |
22-Jan-98 |
20-Nov-98 |
SE1 |
9.9 |
Treatment of acute maxillary sinusitis. |
| CETIRIZINE HYDROCHLORIDE |
PFIZER |
19-835 |
03-Jun-97 |
15-May-98 |
SE1 |
11.4 |
Use in pediatric patients 2 to 5 years of age for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. |
| CETIRIZINE HYDROCHLORIDE |
PFIZER |
20-346 |
16-May-97 |
15-May-98 |
SE1 |
12.0 |
Use in pediatric patients 2 to 5 years of age for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. |
| CILASTATIN SODIUM/IMIPENEM |
MERCK |
50-587 |
08-Apr-97 |
08-Apr-98 |
SE5 |
12.0 |
Treatment of serious infections caused by susceptible strains of designated microorganisms in pediatric patients. |
| CIMETIDINE |
SKB CONS HLTHCARE |
20-238 |
06-Jun-97 |
05-Jun-98 |
SE2 |
12.0 |
Revises the dosage directions for the prevention of meal-induced heartburn from "…take one tablet 30 minutes before eating…" to "…take one tablet just before or anytime up to 30 minutes before eating…". |
| CIPROFLOXACIN |
BAYER |
19-847 |
22-Dec-95 |
03-Apr-98 |
SE5 |
27.4 |
Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients. |
| CIPROFLOXACIN |
BAYER |
19-857 |
22-Dec-95 |
03-Apr-98 |
SE5 |
27.4 |
Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients. |
| CIPROFLOXACIN |
BAYER |
19-858 |
27-Dec-95 |
03-Apr-98 |
SE5 |
27.2 |
Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients. |
| CIPROFLOXACIN |
BAYER |
19-847 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN |
BAYER |
19-847 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN |
BAYER |
19-857 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN |
BAYER |
19-857 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN |
BAYER |
19-858 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN |
BAYER |
19-858 |
08-Oct-97 |
24-Sep-98 |
SE1 |
11.5 |
Treatment of acute sinusitis and chronic bacterial prostatitis infections. |
| CIPROFLOXACIN HYDROCHLORIDE |
BAYER |
19-537 |
27-Dec-95 |
03-Apr-98 |
SE5 |
27.2 |
Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients. |
| CISATRACURIUM BESYLATE |
GLAXO WELLCOME |
20-551 |
24-Oct-97 |
15-Oct-98 |
SE8 |
11.7 |
Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU. |
| CISATRACURIUM BESYLATE |
GLAXO WELLCOME |
20-551 |
19-Jun-97 |
19-Jun-98 |
SLR |
12.0 |
Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU. |
| CLARITHROMYCIN |
ABBOTT LABS |
50-662 |
12-Nov-97 |
16-Sep-98 |
SE1 |
10.1 |
For the use in combination with omeprazole and amoxicillin, as triple therapy for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate Helicobacter pylori. |
| CLINDAMYCIN PHOSPHATE |
PHARMACIA AND UPJOHN |
50-680 |
08-May-95 |
02-Mar-98 |
SE2 |
33.8 |
Provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosis. |
| DESMOPRESSIN ACETATE |
RHONE POULENC RORER |
19-955 |
26-Mar-97 |
25-Mar-98 |
SE1 |
12.0 |
Primary nocturnal enuresis. |
| DEXTROSE |
ABBOTT LABS |
19-445 |
25-Nov-97 |
23-Nov-98 |
SE5 |
11.9 |
Provides for a new Sub-population - Neonates and older infants for approved use as a minimal source of carbohydrates and calories in this population. |
| DEXTROSE |
ABBOTT LABS |
19-445 |
25-Nov-97 |
23-Nov-98 |
SE1 |
11.9 |
Provides for a new indication in the treatment acute symptomatic episodes of hypoglycemia in the neonate and older infant to restore depressed blood glucose levels and control symptoms. |
| DICLOFENAC SODIUM |
CIBA VISION CORP |
20-037 |
30-Sep-96 |
25-Feb-98 |
SE1 |
16.9 |
For the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery. |
| DILTIAZEM HYDROCHLORIDE |
BIOVAIL LABS |
20-401 |
30-Jan-97 |
30-Jan-98 |
SE1 |
12.0 |
Treatment of chronic stable angina. |
| DOCETAXEL |
RHONE POULENC RORER |
20-449 |
22-Dec-97 |
22-Jun-98 |
SE7 |
6.0 |
Treatment in patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed. |
| ENOXAPARIN SODIUM |
RHONE POULENC RORER |
20-164 |
01-Apr-96 |
30-Jan-98 |
SE1 |
22.0 |
Prevention (during and following hospitalization) of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing hip replacement surgery. |
| ENOXAPARIN SODIUM |
RHONE POULENC RORER |
20-164 |
18-Mar-97 |
27-Mar-98 |
SE1 |
12.3 |
Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin. |
| ENOXAPARIN SODIUM |
RHONE POULENC RORER |
20-164 |
28-Feb-97 |
31-Dec-98 |
SE1 |
22.1 |
Inpatient treatment of acute deep vein thrombosis with and without pulmonary embolism, when administered in conjunction with warfarin sodium; and for the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium. |
| EPROSARTAN MESYLATE |
SKB PHARMS |
20-738 |
26-Jan-98 |
28-Oct-98 |
SE2 |
9.0 |
Once daily dosing regimen for the treatment of essential hypertension. |
| ESTROGENS, CONJUGATED |
WYETH AYERST LABS |
04-782 |
22-Feb-94 |
08-Sep-98 |
SE2 |
54.5 |
Prevention of osteoporosis. |
| ESTROGENS/ CONJUGATED MEDROXYPRO-GESTERONE ACETATE |
WYETH AYERST LABS |
20-527 |
09-Jan-97 |
09-Jan-98 |
SE2 |
12.0 |
Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis. |
| ETIDRONATE DISODIUM |
MGI |
19-545 |
28-Dec-94 |
01-Apr-98 |
SLR |
39.1 |
Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration. |
| FAMCICLOVIR |
SMITHKLINE BEECHAM |
20-363 |
13-Jun-97 |
12-Jun-98 |
SE1 |
11.2 |
Treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients at a dose of 500mg twice daily. |
| FAMOTIDINE |
MERCK |
20-325 |
23-Dec-96 |
09-Nov-98 |
SE2 |
22.6 |
Relief of heartburn associated with acid indigestion and sour stomach and for prevention of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages. |
| FINASTERIDE |
MERCK |
20-180 |
19-May-97 |
20-Mar-98 |
SE5 |
10.0 |
Treatment of 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 surgery including transurethral resection of the prostate (TURP) and prostatectomy. |
| FINASTERIDE |
MERCK |
20-180 |
22-Sep-97 |
20-Mar-98 |
SE1 |
5.9 |
Treatment of 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 surgery including transurethral resection of the prostate (TURP) and prostatectomy.. |
| FLUTICASONE PROPIONATE |
GLAXO WELLCOME |
20-121 |
18-Dec-97 |
11-Dec-98 |
SE1 |
11.8 |
Treatment of nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients 4 years and older. |
| GABAPENTIN |
PARKE DAVIS PHARMS |
20-235 |
16-Sep-96 |
29-Sep-98 |
SE2 |
24.4 |
Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy. |
| GEMCITABINE HYDROCHLORIDE |
LILLY |
20-509 |
29-Aug-97 |
25-Aug-98 |
SE1 |
11.9 |
In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. |
| GLIPIZIDE |
PFIZER |
20-329 |
03-Jul-97 |
04-Feb-98 |
SE1 |
7.1 |
Provides for combination therapy with metformin when satisfactory lowering of blood glucose is not achieved with Gulcotrol XL alone. |
| GOSERELIN ACETATE |
ZENECA (UK) |
20-578 |
12-Aug-97 |
27-Jul-98 |
SE1 |
11.5 |
Provides for the use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. |
| GOSERELIN ACETATE |
ZENECA PHARMS |
19-726 |
09-Apr-97 |
09-Apr-98 |
SE1 |
12.0 |
Palliative treatment of advanced carcinoma of the prostate; management of endometriosis. |
| GOSERELIN ACETATE |
ZENECA PHARMS |
19-726 |
12-Aug-97 |
27-Jul-98 |
SE1 |
11.5 |
In combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. |
| HYDROXYUREA |
BRISTOL MYERS SQUIBB |
16-295 |
12-May-97 |
25-Feb-98 |
SE1 |
9.5 |
To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months). |
| INDINAVIR SULFATE |
MERCK RES |
20-685 |
16-Sep-97 |
06-Feb-98 |
SE1 |
4.7 |
Treatment of HIV infection in combination with antiretroviral agents. |
| INTERFERON ALFA-2B, RECOMBINANT/ RIBAVIRIN |
SCHERING PLOUGH RES |
20-903 |
17-Jun-98 |
09-Dec-98 |
SE5 |
5.8 |
Combination therapy for chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy. |
| IPRATROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
20-393 |
01-Apr-97 |
01-Apr-98 |
SE1 |
12.0 |
Symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in children age 6 to 11 years. |
| IPRATROPIUM BROMIDE |
BOEHRINGER INGELHEIM |
20-394 |
19-Dec-97 |
09-Nov-98 |
SE1 |
10.7 |
Symptomatic relief of rhinorrhea associated with the common cold in children age 5 to 11 years. |
| IRINOTECAN HYDROCHLORIDE |
PHARMACIA AND UPJOHN |
20-571 |
22-Apr-98 |
22-Oct-98 |
SE7 |
6.0 |
Treatment of patients with metastatic carcinoma on the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. |
| ISOCARBOXAZID |
HOFFMANN-LA ROCHE |
11-961 |
28-Aug-81 |
18-Aug-98 |
SE1 |
203.8 |
Second line treatment of depression. |
| LAMIVUDINE |
GLAXO WELLCOME |
21-003 |
24-Jun-98 |
08-Dec-98 |
N |
5.5 |
Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. |
| LAMIVUDINE |
GLAXO WELLCOME |
21-004 |
30-Jun-98 |
08-Dec-98 |
N |
5.3 |
Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. |
| LAMOTRIGINE |
GLAXO WELLCOME |
20-241 |
17-Sep-96 |
24-Aug-98 |
SE1 |
23.2 |
Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients. |
| LAMOTRIGINE |
GLAXO WELLCOME |
20-241 |
25-Feb-97 |
14-Dec-98 |
SE1 |
21.6 |
For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED) |
| LAMOTRIGINE |
GLAXO WELLCOME |
20-764 |
08-Sep-98 |
14-Dec-98 |
SE1 |
3.2 |
For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED) |
| LANSOPRAZOLE |
TAP HOLDINGS |
20-406 |
23-Dec-96 |
12-Mar-98 |
SE1 |
14.6 |
Short-term treatment of symptomatic gastroesophageal reflux disease (GERD). |
| LANSOPRAZOLE |
TAP HOLDINGS |
20-406 |
26-Jun-97 |
20-Jul-98 |
SE2 |
12.8 |
10-day dosing regimen for triple therapy, in combination with clarithromycin and amoxicillin, for the eradication of Helicobacter pylori in patients with duodenal ulcer disease. |
| LEUPROLIDE ACETATE |
TAP HOLDINGS |
20-011 |
23-Sep-97 |
09-Apr-98 |
SE1 |
6.5 |
Mana |
