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U.S. Department of Health and Human Services

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Efficacy Supplement Approvals in 1999

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.