| GENERIC NAME |
APPLICANT |
NDA NUMBER |
RECEIPT DATE |
APPROVAL DATE |
SUPP TYPE |
SUPP NUMBER |
PRIORITY REVIEW |
TOTAL APPROVAL TIME (MONTHS) |
INDICATION/DESCRIPTION |
| IBUPROFEN |
WHITEHALL ROBINS |
20-812 |
15-Jun-98 |
12-Jan-00 |
SE5 |
003 |
N |
18.9 |
Provides for the use of Infants' Advil (ibuprofen oral suspension) Concentrated Oral Drops, 50 mg/1.25 mL for ages 6 months to 23 months. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
19-Mar-99 |
18-Jan-00 |
SE1 |
026 |
N |
10.0 |
Provides for a new indication for the use of Pravachol (pravastatin) Tablets in the treatment of patients with Frederickson Type IV. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
19-Mar-99 |
18-Jan-00 |
SE1 |
027 |
N |
10.0 |
Provides for a new indication for the use of Pravachol (pravastatin) Tablets in the treatment of patients with Frederickson Type III. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
19-Mar-99 |
18-Jan-00 |
SE2 |
029 |
N |
10.0 |
Provides for an optional starting dose of 40 mg/day. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
19-Mar-99 |
18-Jan-00 |
SE2 |
030 |
N |
10.0 |
Provides for a change in the recommended time of dosing from administration at bedtime to administration at any time of day with or without food. |
| LIDOCAINE PRILOCAINE |
ASTRAZENECA |
19-941 |
31-Mar-99 |
28-Jan-00 |
SE1 |
011 |
N |
10.0 |
Provides for the use of EMLA Cream as a topical anesthetic for superficial minor surgery of genital mucous membranes and as an adjunct for local infiltration anesthesia in genital mucous membranes. |
| AMPHOTERICIN B LIPOSOME |
FUJISAWA HLTHCARE |
50-740 |
29-Mar-99 |
28-Jan-00 |
SE8 |
001 |
N |
10.0 |
Provides for changes to the CLINICAL STUDIES section, the Pediatric Use subsection, and the ADVERSE REACTIONS section to add safety results from a comparative study conducted with Abelcet (amphotericin B lipid complex). |
| PARICALCITOL |
ABBOTT LABS |
20-819 |
2-Apr-99 |
2-Feb-00 |
SE8 |
003 |
X |
10.1 |
Provides for the addition of long-term (13 month) safety data to the "Clinical Studies" (CLINICAL PHARMACOLOGY) and ADVERSE EVENTS sections of the labeling for Zemplar. |
| LEVOFLOXACIN |
JOHNSON RW |
20-634 |
1-Apr-99 |
2-Feb-00 |
SE1 |
008 |
N |
10.1 |
Provides for the use of LEVAQUIN for the treatment of levofloxacin-susceptible strains of penicillin-resistant Streptococcus pneumoniae in patients with community-acquired pneumonia. |
| LEVOFLOXACIN |
JOHNSON RW |
20-635 |
1-Apr-99 |
2-Feb-00 |
SE1 |
007 |
N |
10.1 |
Provides for the use of LEVAQUIN for the treatment of levofloxacin-susceptible strains of penicillin-resistant Streptococcus pneumoniae in patients with community-acquired pneumonia. |
| LISINOPRIL |
ASTRAZENECA UK |
19-777 |
2-Feb-99 |
7-Feb-00 |
SE1 |
037 |
N |
12.2 |
Provides for changes in several sections of the package insert to incorporate statements concerning the use of high doses of lisinopril to reduce the risk of the combined outcomes of mortality and hospitalization in patients with congestive heart failure. These statements are based on the results of the "Assessment of Treatment with Lisinopril and Survival (ATLAS)" study. |
| EFAVIRENZ |
DUPONT PHARMS |
20-972 |
26-May-99 |
9-Feb-00 |
SE7 |
001 |
N |
8.5 |
For the treatment of HIV-1 infection. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
13-Apr-99 |
10-Feb-00 |
SE1 |
032 |
X |
10.0 |
Provides for a new indication, based on the results of the Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study, for the use of pravastatin in patients with evident coronary heart disease to reduce the risk of total mortality by reducing coronary death. In addition, this supplemental application provides for changes to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Pravachol package insert. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-687 |
2-Mar-99 |
10-Feb-00 |
SE8 |
004 |
N |
11.3 |
Provides for revisions in the PRECAUTIONS section and in the Cephalosporin Class Labeling in the ADVERSE REACTIONS section. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-687 |
12-Apr-99 |
10-Feb-00 |
SE1 |
007 |
X |
10.0 |
In the INDICATIONS AND USAGE section, the community-acquired pneumonia indication was revised to include beta lactamase-producing strains of H. influenzae. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-687 |
28-Apr-99 |
10-Feb-00 |
SE2 |
010 |
X |
9.5 |
Provides for changes in the CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections. Under the GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, two new dosing regimens [100mg every 12 hours (5mg/kg/dose every 12 hours) for 5 to 10 days or 200 mg every 24 hours (10 mg/kg/dose every 12 hours) for 10 days] for the treatment of pharyngitis and/or tonsillitis were added. The every 24 hours for 10 days regimens were subsequently dropped from the labeling. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-687 |
29-Apr-99 |
10-Feb-00 |
SE2 |
011 |
X |
9.4 |
Provides for revisions in the PRECAUTIONS and CLINICAL TRIALS sections. Also, under GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, the age range for children in the dosing tables was expanded to "age 5 months through 12 years." |
| CEFPODOXIME PROXETIL |
SANKYO |
50-688 |
2-Mar-99 |
10-Feb-00 |
SE8 |
006 |
N |
11.3 |
Provides for revisions in the PRECAUTIONS section and in the Cephalosporin Class Labeling in the ADVERSE REACTIONS section. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-688 |
12-Apr-99 |
10-Feb-00 |
SE1 |
008 |
N |
10.0 |
In the INDICATIONS AND USAGE section, the community-acquired pneumonia indication was revised to include beta lactamase-producing strains of H. influenzae. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-688 |
28-Apr-99 |
10-Feb-00 |
SE2 |
011 |
X |
9.5 |
Provides for changes in the CLINICAL PHARMACOLOGY, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections. Under the GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, two new dosing regimens [100mg every 12 hours (5mg/kg/dose every 12 hours) for 5 to 10 days or 200 mg every 24 hours (10 mg/kg/dose every 12 hours) for 10 days] for the treatment of pharyngitis and/or tonsillitis were added. The every 24 hours for 10 days regimens were subsequently dropped from the labeling. |
| CEFPODOXIME PROXETIL |
SANKYO |
50-688 |
29-Apr-99 |
10-Feb-00 |
SE2 |
012 |
X |
9.4 |
Provides for revisions in the PRECAUTIONS and CLINICAL TRIALS sections. Also, under GRANULES FOR ORAL SUSPENSION in the DOSAGE AND ADMINISTRATION section, the age range for children in the dosing tables was expanded to "age 5 months through 12 years." |
| SOTALOL HYDROCHLORIDE |
BERLEX LABS |
21-151 |
22-Jun-98 |
22-Feb-00 |
N |
000 |
N |
20.1 |
Provides for the new indication of prolongation of time to recurrence of symptomatic AFIB/AFL in patients with symptomatic AFIB/AFL, with or without structural heart disease but in the absence of uncompensated congestive heart failure. |
| IBUPROFEN |
MCNEIL CONS |
19-012 |
26-Feb-99 |
25-Feb-00 |
SE1 |
016 |
N |
12.0 |
Treats pain of migraine headache. |
| ESTRADIOL |
NOVARTIS PHARMS |
20-323 |
3-May-99 |
25-Feb-00 |
SE8 |
021 |
N |
9.8 |
Provides for the use of 0.0375 mg Vivelle for the treatment of moderate-to-severe vasomotor symptoms associated with the menopause, treatment of vulvar and vaginal atrophy and treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. Supports removal of the previous labeling statement: "Some women taking the 0.0375 mg/day dosage may experience a delayed onset of action." |
| MONTELUKAST SODIUM |
MERCK RES |
20-830 |
7-May-99 |
3-Mar-00 |
SE1 |
008 |
N |
9.9 |
Prophylaxis for asthma in children 2-5 years of age. |
| IBUPROFEN |
WHITEHALL ROBINS |
20-402 |
17-May-99 |
16-Mar-00 |
SE1 |
005 |
N |
10.0 |
For the treatment of migraine. |
| OLANZAPINE |
LILLY |
20-592 |
3-Dec-97 |
17-Mar-00 |
SE1 |
006 |
N |
27.5 |
Provides for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. |
| TERBINAFINE HYDROCHLORIDE |
NOVARTIS PHARMS |
21-124 |
17-May-99 |
17-Mar-00 |
N |
000 |
N |
10.0 |
Provides for use without prescription of Lamisil AT Spray Pump (terbinafine hydrochloride solution, 1%) and Lamisil AT Solution Dropper (terbinafine hydrochloride solution, 1%) for the treatment of interdigital-type tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum. |
| OLOPATADINE HYDROCHLORIDE |
ALCON |
20-688 |
24-Nov-99 |
20-Mar-00 |
SE1 |
012 |
Y |
3.8 |
Provides for expansion of the indication to the treatment of allergic conjunctivitis. |
| ROSIGLITAZONE MALEATE |
SKB PHARMS |
21-071 |
3-Jun-99 |
3-Apr-00 |
SE1 |
001 |
N |
10 |
Provides for the use of Avandia in combination with a sulfonylurea in patients with type 2 diabetes mellitus when diet and exercise with either single agent does not achieve adequate glycemic control. |
| INSULIN LISPRO |
LILLY |
20-563 |
31-Aug-98 |
4-Apr-00 |
SE8 |
011 |
N |
19.1 |
Provides for changes to the package insert. Use in pediatric patients (PRECAUTIONS). |
| INSULIN LISPRO |
LILLY |
20-563 |
31-Aug-98 |
4-Apr-00 |
SE1 |
012 |
N |
19.1 |
Provides for changes to the package insert. New indication for combination therapy with sulfonylurea agents in patients with Type 2 diabetes (INDICATIONS AND USAGE). |
| INSULIN LISPRO |
LILLY |
20-563 |
31-Aug-98 |
4-Apr-00 |
SE8 |
013 |
N |
19.1 |
Provides for changes to the package insert. Use in geriatric patients (PRECAUTIONS). |
| INSULIN LISPRO |
LILLY |
20-563 |
31-Aug-98 |
4-Apr-00 |
SE2 |
010 |
X |
19.1 |
Provides for changes to the package insert. Addition of postprandial dosing (WARNINGS, DOSAGE AND ADMINISTRATION), addition of the use of Humalog with a sterile diluent (DOSAGE AND ADMINISTRATION), Revised "Renal Impairment" subsection (CLINICAL PHARMACOLOGY), revised "Hepatic Impairment" subsection (CLINICAL PHARMACOLOGY), clarification of "Mixing of Insulins" subsection (PRECAUTIONS), addition of a precaution for patients taking drugs sensitive to serum potassium level (PRECAUTIONS). |
| ESTRADIOL / NORETHINDRONE ACETATE |
NOVO NORDISK PHARM |
21-103 |
11-Jun-99 |
11-Apr-00 |
N |
000 |
N |
10 |
Provides for the use of Activella (estradiol/norethindrone acetate) Tablets for women with an intact uterus for the prevention of postmenopausal osteoporosis. |
| AMINO ACIDS |
BAXTER HLTHCARE |
19-520 |
24-Jun-99 |
12-Apr-00 |
SE8 |
018 |
N |
9.6 |
Provides for changes in the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections in the package insert. |
| AMINO ACIDS |
BAXTER HLTHCARE |
20-147 |
30-Jun-99 |
12-Apr-00 |
SE8 |
006 |
N |
9.4 |
Provides for changes in the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections in the package insert. |
| AMINO ACIDS WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM |
BAXTER HLTHCARE |
20-678 |
7-Jul-99 |
12-Apr-00 |
SE8 |
003 |
N |
9.2 |
Provides for changes in the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections in the package insert. |
| AMINO ACIDS IN DEXTROSE |
BAXTER HLTHCARE |
20-734 |
1-Jul-99 |
12-Apr-00 |
SE8 |
003 |
N |
9.4 |
Provides for changes in the WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections in the package insert. |
| CAFFEINE CITRATE |
OPR DEVELOP LP |
20-793 |
12-Oct-99 |
12-Apr-00 |
SE3 |
001 |
N |
6 |
Provides for the use of Cafcit (caffeine citrate) Oral Solution for the short term treatment of apnea of prematurity in infants between 28 and < 33 weeks gestational age. |
| SOMATROPIN |
GENENTECH INC |
19-676 |
14-Jun-99 |
13-Apr-00 |
SE2 |
016 |
N |
10 |
Provides for the addition of a higher dose of Nutropin (somatropin [rDNA origin] for injection) for pubertal patients to the DOSAGE AND ADMINISTRATION section of the product insert. |
| SOMATROPIN [rDNA ORIGIN] |
GENENTECH INC |
20-522 |
28-Jun-99 |
13-Apr-00 |
SE2 |
013 |
N |
9.5 |
Provides for the addition of a higher dose of Nutropin AQ (somatropin [rDNA origin] for injection) for pubertal patients to the DOSAGE AND ADMINISTRATION section of the product insert. |
| EPOPROSTENOL SODIUM |
GLAXO WELLCOME |
20-444 |
14-Dec-98 |
14-Apr-00 |
SE1 |
003 |
Y |
16 |
Provides for the use of Flolan (epoprostenol sodium) for Injection for the long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in (New York Heart Association) Class III & Class IV patients who do not respond adequately to conventional therapy. |
| RISEDRONATE SODIUM |
PROCTER GAMBLE PHARM |
20-835 |
18-Dec-98 |
14-Apr-00 |
SE1 |
002 |
X |
15.9 |
Provides for a new indication for the prevention of postmenopausal osteoporosis and for a new 5 mg strength tablet. |
| RISEDRONATE SODIUM |
PROCTER GAMBLE PHARM |
20-835 |
18-Dec-98 |
14-Apr-00 |
SE1 |
003 |
X |
15.9 |
Provides for a new indication for the treatment of postmenopausal osteoporosis and for a new 5 mg strength tablet. |
| RISEDRONATE SODIUM |
PROCTER GAMBLE PHARM |
20-835 |
18-Dec-98 |
14-Apr-00 |
SE1 |
001 |
Y |
15.9 |
Provides for a new indication for the treatment of corticosteroid-induced osteoporosis and for a new 5 mg strength tablet. |
| RISEDRONATE SODIUM |
PROCTER GAMBLE PHARM |
20-835 |
30-Aug-99 |
14-Apr-00 |
SE1 |
004 |
Y |
7.5 |
Provides for a new indication for the prevention of corticosteroid-induced osteoporosis and for a new 5 mg strength tablet. |
| IRINOTECAN HYDROCHLORIDE |
PHARMACIA AND UPJOHN |
20-571 |
20-Oct-99 |
20-Apr-00 |
SE1 |
009 |
Y |
6 |
Provides for the use of Camptosar (irinotecan hydrochloride injection) Injection as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. |
| FENOFIBRATE |
ABBOTT LABS |
19-304 |
1-Jul-99 |
24-Apr-00 |
SE1 |
005 |
X |
9.8 |
Provides for the treatment of hypercholesterolemia as adjunctive therapy to diet for the reduction of low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides, and apolipoprotein B (Apo B) in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb). |
| ZANAMIVIR |
GLAXO WELLCOME |
21-036 |
26-Oct-99 |
26-Apr-00 |
SE1 |
001 |
Y |
6 |
Provides for the use of Relenza for the treatment of uncomplicated acute illness due to influenza A and B in pediatric patients 7 years and older who have been symptomatic for no more than 2 days. |
| SIMVASTATIN |
MERCK |
19-766 |
1-Jul-99 |
27-Apr-00 |
SE2 |
040 |
X |
9.9 |
Amends the DOSAGE AND ADMINISTRATION section of the Zocor package insert to add 40 mg daily as an optional starting dose in patients who require a large reduction in LDL-C (more than 45%). |
| SEVELAMER HCL |
GELTEX |
20-926 |
6-Jul-99 |
5-May-00 |
SE2 |
002 |
N |
10 |
Indicated for the reduction of serum phosphorus in patients with end stage renal disease. |
| NELFINAVIR MESYLATE |
AGOURON |
20-778 |
20-Jul-99 |
17-May-00 |
SE7 |
012 |
N |
9.9 |
Provides for use in combination with other antiretroviral agents, for the treatment of HIV-1 infection. |
| NELFINAVIR MESYLATE |
AGOURON |
20-779 |
19-Jul-99 |
17-May-00 |
SE7 |
026 |
N |
10 |
Provides for use in combination with other antiretroviral agents, for the treatment of HIV-1 infection. |
| FOLLITROPIN ALFA |
SERONO LABS |
20-378 |
27-Jul-99 |
24-May-00 |
SE1 |
006 |
N |
9.9 |
Gonal-F is indicated 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. |
| ENOXAPARIN SODIUM |
AVENTIS PHARM PROD |
20-164 |
4-Nov-99 |
30-May-00 |
SE8 |
034 |
N |
6.8 |
Provides for the following change: in the PRECAUTIONS section of the package insert, the addition of a "Geriatric use" subsection. |
| AZELASTINE HYDROCHLORIDE |
WALLACE LABS |
20-114 |
14-Jun-99 |
30-May-00 |
SE1 |
005 |
X |
11.5 |
Treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older. |
| FLUDEOXYGLUCOSE F-18 |
DOWNSTATE CLINICAL PET CENTER |
20-306 |
30-Mar-00 |
2-Jun-00 |
SE1 |
005 |
N |
2.1 |
(a)Assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. (b) Assessment of patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. |
| PRAVASTATIN SODIUM |
BRISTOL MYERS SQUIBB |
19-898 |
19-Mar-99 |
9-Jun-00 |
SE1 |
031 |
N |
14.7 |
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). |
| AMPHOTERICIN B LIPOSOME |
FUJISAWA HLTHCARE |
50-740 |
7-Jul-99 |
16-Jun-00 |
SE1 |
002 |
N |
11.3 |
Provides for the use of AmBisome (amphotericin B) liposome for injection, for treatment of cryptococcal meningitis in HIV infected patients. |
| PACLITAXEL |
BRISTOL MYERS SQUIBB |
20-262 |
21-Dec-99 |
20-Jun-00 |
SE2 |
036 |
Y |
6 |
Provides for a 3-hour infusion of Taxol (paclitaxel) Injection given every 3 weeks at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg/m2 for the first-line treatment of advanced ovarian cancer. |
| SOMATROPIN |
PHARMACIA AND UPJOHN |
20-280 |
23-Dec-99 |
20-Jun-00 |
SE1 |
023 |
Y |
5.9 |
Treatment of pediatric patients with Prader-Willi syndrome. |
| RIZATRIPTAN BENZOATE |
MERCK |
20-864 |
27-Oct-99 |
21-Jun-00 |
SE8 |
002 |
N |
7.8 |
Provides for the use of Maxalt Tablets and Maxalt-MLT in adolescent migraine patients. |
| RIZATRIPTAN BENZOATE |
MERCK |
20-865 |
27-Oct-99 |
21-Jun-00 |
SE8 |
004 |
N |
7.8 |
Provides for the use of Maxalt Tablets and Maxalt-MLT in adolescent migraine patients. |
| PRAVASTATIN |
BRISTOL MYERS SQUIBB |
19-898 |
26-Aug-99 |
23-Jun-00 |
SE8 |
037 |
N |
9.9 |
Provides for change to the Clinical Pharmacology, Pharmacokinetics/Metabolism subsection regarding age-related differences in mean AUC and mean cumulative urinary excretion of pravastatin and for the addition of a "Geriatric Use" subsection to the Precautions section of the Provachol package insert. |
| TAMOXIFEN CITRATE |
ASTRAZENECA PHARMS |
17-970 |
29-Dec-99 |
