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U.S. Department of Health and Human Services

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Efficacy Supplement Approvals in 2000

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 29-Jun-00 SE1 046 Y 6 In women with DCIS (ductal carcinoma in situ), following breast cancer and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer.
SALMETEROL XINAFOATE GLAXO WELLCOME 20-236 1-Sep-99 29-Jun-00 SE8 019 X 9.9 Provides for the use of salmeterol xinafoate with inhaled corticosteroids.
SALMETEROL XINAFOATE GLAXO WELLCOME 20-692 1-Sep-99 29-Jun-00 SE8 011 X 9.9 Provides for the use of salmeterol xinafoate with inhaled corticosteroids.
FLUOXETINE HYDROCHLORIDE LILLY 18-936 22-Dec-98 6-Jul-00 SE1 058 N 18.5 Provides for the treatment of PMDD (premenstrual dysphoric disorder).
AMLODIPINE BESYLATE PFIZER 19-787 2-Jul-99 12-Jul-00 SE8 020 N 12.4 Provides for extensive revisions of the precautions:Drug interactions subsection.
VENLAFAXINE HYDROCHLORIDE WYETH AYERST 20-699 15-Sep-99 13-Jul-00 SE8 007 N 9.9 Changes to labeling based on clinical data.
CERIVASTATIN SODIUM BAYER 20-740 23-Sep-99 21-Jul-00 SE2 008 N 9.9 For the reduction of elevated LDL-cholesterol in a new, higher strength tablet, 0.8 mg, and for extension of the dosage range to 0.8 mg daily.
CERIVASTATIN SODIUM BAYER 20-740 23-Sep-00 21-Jul-00 SE1 013 N 9.9 For increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb).
DIDANOSINE BRISTOL-MYERS SQUIBB 20-154 28-Apr-00 24-Jul-00 SE8 033 N 2.9 Provides for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the Videx label and Videx patient package inserts, and the recommendation that twice-daily administration of Videx is the preferred dosing frequency.
DIDANOSINE BRISTOL-MYERS SQUIBB 20-155 28-Apr-00 24-Jul-00 SE8 024 N 2.9 Provides for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the Videx label and Videx patient package inserts, and the recommendation that twice-daily administration of Videx is the preferred dosing frequency.
DIDANOSINE BRISTOL-MYERS SQUIBB 20-156 28-Apr-00 24-Jul-00 SE8 025 N 2.9 Provides for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the Videx label and Videx patient package inserts, and the recommendation that twice-daily administration of Videx is the preferred dosing frequency.
MYCOPHENOLATE MOFETIL ROCHE GLOBAL 50-722 4-Oct-99 28-Jul-00 SE1 005 N 9.8 Provides for the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants.
MYCOPHENOLATE MOFETIL ROCHE GLOBAL 50-723 12-Jul-00 28-Jul-00 SE1 005 N 0.5 Provides for the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants.
MYCOPHENOLATE MOFETIL HYDROCHLORIDE ROCHE GLOBAL 50-758 24-May-00 28-Jul-00 SE1 004 N 2.1 Provides for the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants.
MYCOPHENOLATE MOFETIL ROCHE GLOBAL 50-759 12-Jul-00 28-Jul-00 SE1 006 N 0.5 Provides for the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants.
TRETINOIN JOHNSON & JOHNSON 19-963 1-Sep-98 1-Aug-00 SE8 005 X 23.0 Changes to labeling based on clinical data.
ENOXAPARIN SODIUM AVENTIS PHARMS 20-164 24-Nov-98 3-Aug-00 SE8 020 X 20.3 Provides for changes to the CLINICAL TRIALS section, the "Unstable Angina and Non-Q-Wave Myocardial Infarction" subsection, regarding the one year follow-up period.
DALTEPARIN SODIUM PHARMACIA & UPJOHN 20-287 1-Mar-00 3-Aug-00 SE2 018 N 5.1 Provides for the addition of a postoperative dosing regimen for Fragmin; and content changes to the package insert including the CLINICAL TRIALS section, "Hip Replacement Surgery" subsection; the ADVERSE REACTIONS section, "Hip Replacement Surgery" subsection; and the DOSAGE AND ADMINISTRATION section, "Hip Replacement Surgery" subsection.
ETODOLAC WYETH AYERST 20-584 12-Oct-99 11-Aug-00 SE5 005 X 10.0 Provides for juvenile rheumatoid arthritis.
SULFASALAZINE PHARMACIA & UPJOHN 21-243 18-Oct-99 18-Aug-00 N 000 N 10.0 Provides for the treatment of pediatric patients with polyarticular course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.
NIMODIPINE BAYER 18-869 1-Mar-00 22-Aug-00 SE1 010 Y 5.7 Provides for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).
AMMONIUM LACTATE BRISTOL-MYERS SQUIBB 20-508 26-Aug-99 25-Aug-00 SE8 005 X 12.0 Provides for the treatment of ichthyosis vulgaris and xerosis in pediatric patients as young as 2 years old.
CIPROFLOXACIN HYDROCHLORIDE BRAYER 19-537 1-Mar-00 30-Aug-00 SE1 038 Y 6.0 For inhalational anthrax (post-exposure).
CIPROFLOXACIN HYDROCHLORIDE BAYER 19-847 2-Mar-00 30-Aug-00 SE1 024 Y 6.0 For inhalational anthrax (post-exposure).
CIPROFLOXACIN HYDROCHLORIDE BAYER 19-857 2-Mar-00 30-Aug-00 SE1 027 Y 6.0 For inhalational anthrax (post-exposure).
CIPROFLOXACIN HYDROCHLORIDE BAYER 19-858 2-Mar-00 30-Aug-00 SE1 021 Y 6.0 For inhalational anthrax (post-exposure).
CIPROFLOXACIN HYDROCHLORIDE BAYER 20-780 2-Mar-00 30-Aug-00 SE1 008 Y 6.0 For inhalational anthrax (post-exposure).
ANASTROZOLE ASTRAZENECA 20-541 1-Nov-99 1-Sep-00 SE1 006 N 10.0 Indicated for the first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.
LEVOFLOXACIN JOHNSON RW 20-634 8-Nov-99 8-Sep-00 SE1 013 N 10.0 Provides for the treatment of complicated skin and skin structure infections.
LEVOFLOXACIN JOHNSON RW 20-635 8-Nov-99 8-Sep-00 SE1 010 N 10.0 Provides for the treatment of complicated skin and skin structure infections.
AZELASTINE HYDROCHLORIDE WALLACE LABS 20-114 15-Nov-99 15-Sep-00 SE5 006 N 10.0 Provides for the treatment of symptoms of vasomotor rhinitis in adults and children 12 years of age and older.
GLIMEPIRIDE AVENTIS PHARMS 20-496 26-Aug-98 27-Sep-00 SE8 005 N 25.1 Provides for the addition of a Geriatric Use subsection to the PRECAUTIONS section.
FLUVOXAMINE MALEATE SOLVAY 20-243 2-Dec-99 28-Sep-00 SE2 021 N 9.9 To treat obsessive compulsive disorder.
ALENDRONATE SODIUM MERCK 20-560 31-Mar-00 29-Sep-00 SE1 023 N 6.0 Provides for the treatment to increase bone mass in men with osteoporosis.
RAMIPRIL KING PHARMS 19-901 18-Jan-00 4-Oct-00 SE1 028 N 8.5 Reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes.
GABAPENTIN PARKE DAVIS PHARMS 20-235 15-Dec-99 12-Oct-00 SE1 015 N 9.9 Provides for the use of Neurontin as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above.
GABAPENTIN PARKE DAVIS 20-882 15-Dec-99 12-Oct-00 SE1 002 N 9.9 Provides for the use of Neurontin as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above.
GABAPENTIN PARKE DAVIS 21-129 15-Dec-99* 12-Oct-00 SE8 005 X 9.9 Provides for the use of Neurontin as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above.
MITOXANTRONE HCL IMMUNEX 21-120 4-Jun-99 13-Oct-00 N 000 Y 16.3 Indicated for reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis.
ALENDRONATE SODIUM MERCK 20-560 22-Dec-99 20-Oct-00 SE2 021 X 10.0 Provides for new dosage strength for once weekly dosing for the prevention of postmenopausal osteoporosis.
ALENDRONATE SODIUM MERCK 20-560 22-Dec-99 20-Oct-00 SE2 022 X 10.0 Provides for new dosage strength for once weekly dosing for the treatment of postmenopausal osteoporosis.
CLARITHROMYCIN ABBOTT LABS 50-662 20-Dec-99 20-Oct-00 SE1 029 N 10.0 Provides for the addition of Haemophilus influenzae to the previously approved indication of community-acquired pneumonia for Biaxin Filmtab (clarithromycin tablets).
RIFAPENTINE AVENTIS PHARMS 21-024 21-Dec-99 20-Oct-00 SE7 005 N 10.0 Indicated for the treatment of pulmonary tuberculosis.
FLUVASTATIN SODIUM NOVARTIS PHARM 20-261 23-Dec-99 23-Oct-00 SE8 024 N 10.0 Provides for changes to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the package insert.
INDINAVIR SULFATE MERCK RES 20-685 23-Dec-99 23-Oct-00 SE8 043 N 10.0 Provides for pediatric safety data in the CLINICAL PHARMACOLOGY, WARNINGS, and PRECAUTIONS sections of the label.
IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM 20-394 30-Dec-99 27-Oct-00 SE1 004 X 9.9 Provides for the use of Atrovent Nasal Spray 0.06% for symptomatic relief of rhinorrhea associated with seasonal allergic rhinitis in patients 5 years of age and older.
ROPIVACAINE HCL MONOHYDRATE ASTRAZENECA 20-533 28-Sep-98 2-Nov-00 SE2 002 N 25.2 Indicated for the production of local or regional anesthesia for surgery and for acute pain management.
SIMVASTATIN MERCK 19-766 11-Jan-00 7-Nov-00 SE8 042 X 9.9 Provides for changes to the Zocor package insert as follows: 1) addition of information to the Pharmacokinetics subsection of the CLINICAL PHARMACOLOGY section regarding age-related differences in mean plasma HMG-CoA reductase inhibitory activity; 2) addition of information to the Clinical Studies subsection of the CLINICAL PHARMACOLOGY section regarding the clinical efficacy of simvastatin in the elderly population derived from the Scandinavian Simvastatin Survival Study (4S); and 3) addition of a Geriatric Use subsection to the PRECAUTIONS section.
OLANZAPINE LILLY 20-592 17-Dec-99 9-Nov-00 SE1 011 N 10.8 Indicated for the maintenance of treatment response.
AZITHROMYCIN PFIZER 50-670 13-Jan-00 13-Nov-00 SE1 015 X 10.0 Provides for revision to the combined package insert for the use of Zithromax Tablets, 600 mg, in combination with ethambutol, for the treatment of disseminated Mycobacterium avium complex (MAC) infections in persons with advanced HIV infection.
AZITHROMYCIN PFIZER CENTRAL RES 50-693 13-Jan-00 13-Nov-00 SE1 003 X 10.0 Provides for revision to the combined package insert for the use of Zithromax Tablets, 600 mg, in combination with ethambutol, for the treatment of disseminated Mycobacterium avium complex (MAC) infections in persons with advanced HIV infection.
AZITHROMYCIN PFIZER CEN RES 50-730 13-Jan-00 13-Nov-00 SE1 005 N 10.0 Provides for revision to the combined package insert for the use of Zithromax Tablets, 600 mg, in combination with ethambutol, for the treatment of disseminated Mycobacterium avium complex (MAC) infections in persons with advanced HIV infection.
ENOXAPARIN SODIUM AVENTIS PHARMS 20-164 10-Dec-99 17-Nov-00 SE1 036 Y 11.3 Provides for the use of Lovenox (enoxaparin sodium) for the thromboprophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
OSELTAMIVIR PHOSPHATE ROCHE 21-087 22-May-00 17-Nov-00 SE1 002 Y 5.9 For the prophylaxis of influenza virus in adults and adolescents 13 years and older.
LANSOPRAZOLE TAP PHARM 20-406 22-Jul-99 30-Nov-00 SE1 033 X 16.3 Provides for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use; and for reducing the risk of NSAID-associated gastric ulcers in patients with history of documented gastric ulcer who require the use of a NSAID.
TACROLIMUS FUJISAWA HLTHCARE 50-708 5-Oct-98 1-Dec-00 SE8 013 N 25.9 Provides for revisions to the labeling for Prograf Capsules and Injection based on the following Phase 4 commitments: 1) Conduct a study to confirm the pharmacokinetics of Prograf (tacrolimus) in patients with mild and severe hepatic dysfunction. 2) Submit for review on completion of the study data being currently collected in the ongoing study to determine the pharmacokinetics of Prograf (tacrolimus) in patients with mild and severe hepatic dysfunction. 3) Conduct in vivo drug interaction studies to screen for possible interactions with drugs to be used concomitantly with Prograf (tacrolimus). Based on the in vitro results, in vivo drug interaction studies with "key" drugs should be conducted.
TACROLIMUS FUJISAWA HLTHCARE 50-709 5-Oct-98 1-Dec-00 SE8 010 N 25.9 Provides for revisions to the labeling for Prograf Capsules and Injection based on the following Phase 4 commitments: 1) Conduct a study to confirm the pharmacokinetics of Prograf (tacrolimus) in patients with mild and severe hepatic dysfunction. 2) Submit for review on completion of the study data being currently collected in the ongoing study to determine the pharmacokinetics of Prograf (tacrolimus) in patients with mild and severe hepatic dysfunction. 3) Conduct in vivo drug interaction studies to screen for possible interactions with drugs to be used concomitantly with Prograf (tacrolimus). Based on the in vitro results, in vivo drug interaction studies with "key" drugs should be conducted.
LORATADINE SCHERING 20-641 26-Nov-99 4-Dec-00 SE5 007 N 12.3 Indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 years or age and older.
DEXTROSE BAXTER HLTHCARE 17-521 6-Mar-00 7-Dec-00 SE8 061 N 9.1 Provides for changes in the WARNINGS section and the addition of a Pediatric Use subsection to the PRECAUTIONS section of the package insert labeling.
FOMEPIZOLE ORPHAN MEDCL 20-696 9-Jun-00 8-Dec-00 SE1 001 N 6.0 Provides for the use of Antizol for suspected or confirmed methanol poisoning, either used alone or in combination with hemodialysis.
RIZATRIPTAN BENZOATE MERCK 20-864 13-Mar-00 11-Dec-00 SE8 005 N 9.0 Provides for labeling changes regarding the relationship of menses and migraine attacks.
RIZATRIPTAN BENZOATE MERCK 20-865 13-Mar-00 11-Dec-00 SE8 006 N 9.0 Provides for labeling changes regarding the relationship of menses and migraine attacks.
METFORMIN HCL BRISTOL MYERS SQUIBB 20-357 15-Feb-00 15-Dec-00 SE5 019 N 10.0 Indicated for the treatment of type 2 diabetes in pediatric patients (ages 10-16 years).
ABACAVIR SULFATE GLAXO WELLCOME 20-977 17-Dec-99 15-Dec-00 SE8 002 N 12.0 Provides 48-week data from Study CAAB3005 comparing abacavir plus lamivudine plus zidovudine to indinavir plus lamivudine plus zidovudine and the results from the methadone/abacavir drug interaction study for inclusion in the abacavir label.
ABACAVIR SULFATE GLAXO WELLCOME 20-978 17-Dec-99 15-Dec-00 SE8 002 N 12.0 Provides 48-week data from Study CAAB3005 comparing abacavir plus lamivudine plus zidovudine to indinavir plus lamivudine plus zidovudine and the results from the methadone/abacavir drug interaction study for inclusion in the abacavir label.
FLUVASTATIN SODIUM NOVARTIS PHARM 20-261 22-Feb-00 18-Dec-00 SE1 025 N 9.9 Provides for the addition of data on the HDL-raising effects of Lescol (fluvastatin sodium) at daily doses of 20 mg, 40 mg, and 80 mg (40 mg twice a day).
MYCOPHENOLATE MOFETIL ROCHE GLOBAL DEV 50-722 22-Feb-00 20-Dec-00 SE5 007 N 9.9 Indicated for the prevention of acute rejection in pediatric renal transplant patients.
MYCOPHENOLATE MOFETIL ROCHE GLOBAL DEV 50-723 24-May-00 20-Dec-00 SE5 004 N 6.9 Indicated for the prevention of acute rejection in pediatric renal transplant patients.
MYCOPHENOLATE MOFETIL ROCHE GLOBAL DEV 50-759 24-May-00 20-Dec-00 SE5 005 N 6.9 Indicated for the prevention of acute rejection in pediatric renal transplant patients.
                   
* This supplement was reviewed concurrently with the NDA received 15-Dec-99. Review times are based on this receipt date.                

 

 

 

 

This supplement was reviewed concurrently with the NDA received 15-Dec-99.  Review times are based on this receipt date.  This list is updated quarterly.  Last updated 12/31/00.