Drugs

Efficacy Supplement Approvals in 1999

GENERIC NAMEAPPLICANTNDA NUMBERRECEIPT DATEAPPROVAL DATESUPP TYPESUPP NUMBERPRIOITY REVIEWTOTAL APPROVAL TIME (MONTHS)INDICATION /
DESCRIPTION
ATOVAQUONEGLAXO WELLCOME20-50003/06/9801/05/99SE15N10.0Prevention of Pneumocystis carinii pneumonia (PCP).
TERBINAFINE HYDROCHLORIDENOVARTIS PHARMS20-53912/20/9601/05/99SE83X24.5Expansion of labeling to include patients with onychomycosis of fingernail or toenail even when associated with non-dermatophytes.
NICOTINENOVARTIS20-07602/03/9801/07/99SE413N11.1Relief of nicotine withdrawal symptoms.
AMOXICILLIN CLARITHROMYCIN LANSOPRAZOLETAP HOLDINGS50-75710/06/9801/22/99SE22N3.6Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence.
LEUPROLIDE ACETATETAP HOLDINGS20-70804/13/9802/11/99SE85N10.0Comparability demonstrated between 3.75 mg and 11.25 mg depot in the treatment of endometriosis and uterine fibroids.
GLIMEPIRIDEHOECHST MARION RSSL20-49611/04/9702/24/99SE12N15.7Concomitant use with metformin when diet, exercise, and Amaryl alone do not result in adequate glycemic control.
FLUNISOLIDEDURA18-14804/07/8902/25/99SE223 118.7Treatment of the nasal symptoms of seasonal and perennial rhinitis.
ESTRADIOLBERLEX LABS20-99405/05/9803/05/99N0N10.0Prevention 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 SODIUMNOVARTIS PHARM20-26107/22/9803/08/99SE118N7.5Reduction of triglycerides and ApoB in patients with primary hypercholestrolemia and mixed dyslipidemia.
FLUVASTATIN SODIUMNOVARTIS PHARM20-26107/22/9803/08/99SE822N7.5Provides for a reduction in the recommended frequency of Liver Function Testing (LFT) and eliminates semi-annual LFT monitoring.
RANITIDINE HYDROCHLORIDEGLAXO WELLCOME20-74505/13/9803/08/99SE11N9.8Prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages.
CIDOFOVIRGILEAD20-63803/09/9803/09/99SE83N12.0Provides for the use of Vistide (cidofovir injection) 75 mg/mL for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS.
TERBINAFINE HYDROCHLORIDENOVARTIS20-98003/30/9803/09/99N0N11.3Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm).
LOVASTATINMERCK19-64304/29/9803/11/99SE155N10.4Primary 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 PRILOCAINEASTRA PHARMS19-94105/15/9803/11/99SE810N9.9Expands the pediatric indication to children younger than one month of age to birth (with a gestational age of 37 weeks or greater)
VENLAFAXINE HYDROCHLORIDEWYETH AYERST LABS20-69901/30/9803/11/99SE11N13.3Treatment of generalized anxiety disorder as a new indication.
LAMIVUDINEGLAXO WELLCOME20-56403/30/9803/23/99SE87N11.8Provides for the inclusion of additional pediatric information into the labeling.
LAMIVUDINEGLAXO WELLCOME20-59603/30/9803/23/99SE87N11.8Provides for the inclusion of additional pediatric information into the labeling.
DALTEPARIN SODIUMPHARMACIA AND UPJOHN20-28704/17/9703/30/99SE18N23.4Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism, in patients undergoing hip replacement surgery.
IBUPROFENMCNEIL CONS PRODS20-60306/15/9804/15/99SE53N10.0Provides for dosing for ages 6 months to 2 years.
MUPIROCINSMITHKLINE BEECHAM50-59104/27/9804/22/99SE822N11.8"Pediatric Use" subsection added to labeling.
ISOPROTERENOL HYDROCHLORIDEABBOTT LABS10-51501/05/9805/04/99SE122N15.9"Pediatric Use" subsection added to labeling.
PAROXETINE HYDROCHLORIDESKB PHARMS20-03105/06/9805/11/99SE123N12.2Treatment of social anxiety disorder.
IBUTILIDE FUMARATEPHARMACIA AND UPJOHN20-49112/22/9705/13/99SE81N16.7Provides for additions to the labeling regarding post-cardiac surgery patients.
CERIVASTATINBAYER20-74007/17/9805/24/99SE22N10.2Provides for a new 0.4 mg dosage strength.
DALTEPARIN SODIUMPHARMACIA AND UPJOHN20-28706/01/9805/25/99SE110N11.8Treatment of unstable angina and non-Q-wave myocardial infarction and for the prevention of ischemic complications in patients on concurrent aspirin therapy.
RITONAVIRABBOTT LABS20-65905/26/9805/26/99SE713N12.0For the treatment of HIV infection in combination with other antiretroviral agents.
RITONAVIRABBOTT LABS20-68005/26/9805/26/99SE711N12.0For the treatment of HIV infection in combination with other antiretroviral agents.
ETODOLACWYETH AYERST LABS20-58411/12/9705/27/99SE23N18.4Provides 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 SULFATE3M PHARMACEUTICALS20-50306/02/9806/02/99SE111N12.0Provides 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 SODIUMMERCK20-56006/08/9806/08/99SE813N12.0Provides for the extension of the use of the drug from three to five years for the treatment of postmenopausal osteoporosis.
ALENDRONATE SODIUMMERCK20-56011/26/9706/16/99SE112N18.6Treatment 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.
TROGLITAZONEPARKE DAVIS PHARMS20-72011/19/9806/16/99SE112N6.9Provides for the use in combination with metformin and sulfonylurea in patients with type 2 diabetes.
FLUTICASONE PROPIONATEGLAXO WELLCOME19-95806/09/9506/17/99SE58N48.3Provides for the use in pediatric patients 3 months of age or older with corticosteroid-responsive dermatoses.
AMIFOSTINEUS BIOSCIENCE20-22112/24/9806/24/99SE112Y6.0To 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 HYDROCHLORIDEALZA50-71812/29/9806/28/99SE16Y6.0Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens.
DIDANOSINEBRISTOL MYERS SQUIBB20-15407/01/9807/01/99SE128N12.0Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection.
DIDANOSINEBRISTOL MYERS SQUIBB20-15507/01/9807/01/99SE120N12.0Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection.
DIDANOSINEBRISTOL MYERS SQUIBB20-15607/01/9807/01/99SE121N12.0Expands the monotherapy indication to provide for the use of Videx in combination with other antiretroviral agents for the treatment of HIV-1 infection.
STAVUDINEBRISTOL MYERS SQUIBB20-41207/01/9807/01/99SE110N12.0Expands the monotherapy indication to provide for the use of Zerit in combination with other antiretroviral agents for the treatment of HIV-1 infection.
STAVUDINEBRISTOL MYERS SQUIBB20-41307/01/9807/01/99SE13N12.0Expands the monotherapy indication to provide for the use of Zerit in combination with other antiretroviral agents for the treatment of HIV-1 infection.
LANSOPRAZOLETAP HOLDINGS20-40604/16/9807/06/99SE428N14.7Day and night heartburn.
CALCIPOTRIENEWESTWOOD SQUIBB20-27307/08/9807/07/99SE84N12.0Treatment of plaque psoriasis in adults
CEFDINIRPARKE DAVIS50-74907/15/9807/14/99SE22N12.05-day dosing regimen (7mg/kg BID) for the treatment of acute otitis media (10-day regimen previously approved).
TOPIRAMATEJOHNSON RW20-50508/01/9707/23/99SE11N23.7Use as adjunctive therapy in pediatric patients ages 2-16 years with partial onset seizures.
TOPIRAMATEJOHNSON RW20-84402/01/9907/23/99SE11N5.7Use as adjunctive therapy in pediatric patients ages 2-16 years with partial onset seizures.
TERBINAFINENOVARTIS PHARMS20-84610/23/9807/26/99SE11N9.1Tinea cruris.
GRANISETRON HYDROCHLORIDESKB PHARMS20-30507/27/9807/27/99SE14N12.0Prevention of nausea and vomiting associated with radiation, including total body irradiation (TBI) and fractionated abdominal radiation.
SIMVASTATINMERCK19-76610/19/9808/05/99SE132N9.5For the additional indication of increasing HDL-C in patients with primary hypercholestrolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb).
ACARBOSEBAYER20-48208/17/9808/16/99SE810N12.0Management of type 2 diabetes mellitus.
MIGLITOLPHARMACIA AND UPJOHN20-68208/19/9808/16/99SE81N11.9For use in the management of non-insulin-dependent diabetes mellitus (NIDDM).
FLUOCINOLONE ACETONIDEHILL DERM19-45208/18/9808/18/99SE115N12.0Treatment of atopic dermatitis in pediatric patients 6 years of age or older.
CEFUROXIME AXETILGLAXO WELLCOME50-60509/15/9808/24/99SE832N11.3Treatment of acute bacterial maxillary sinusitis in pediatric patents.
CEFUROXIME AXETILGLAXO WELLCOME50-67209/15/9808/24/99SE814N11.3Treatment of acute bacterial maxillary sinusitis in pediatric patents.
POLYMYXIN B SULFATE NEOMYCIN SULFATE HYDROCORTISONEMONARCH PHARMS50-47903/24/9908/26/99SE815N5.1Treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics.
ONDANSETRON HYDROCHLORIDEGLAXO WELLCOME20-10308/28/9808/27/99SE115N12.0Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin.
MENOTROPINSFERRING PHARMS21-04710/28/9808/27/99N0N10.0For use in conjunction with hCG for multiple follicular development and ovulation induction in patients who have previously received pituitary suppression.
BUPROPION HYDROCHLORIDEGLAXO WELLCOME20-71108/05/9709/10/99SE41N25.2For use as an aid to smoking cessation.
BUPROPION HYDROCHLORIDEGLAXO WELLCOME20-71102/13/9809/10/99SE23N18.9For use as an aid to smoking cessation.
NIACINKOS PHARMS20-38105/07/9909/13/99SE27N4.2Provides 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.
ZAFIRLUKASTZENECA20-54709/18/9809/17/99SE17N12.0Prophylaxis and chronic treatment of asthma in pediatric patients 7-11 years of age.
EPTIFIBATIDECOR20-71810/13/9809/20/99SE82N11.2Treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention.
METFORMIN HYDROCHLORIDEBRISTOL MYERS SQUIBB20-35703/26/9909/22/99SE817N5.9Provides 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 HYDROCHLORIDELILLY20-81503/31/9909/30/99SE13Y6.0Treatment of osteoporosis in postmenopausal women.
TOPIRAMATEJOHNSON RW20-50508/01/9710/01/99SE13N26.0Provides for the use of Topamax as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures.
TOPIRAMATEJOHNSON RW20-84404/02/9910/01/99SE14N6.0Provides for the use of Topamax as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures.
TROGLITAZONESANKYO20-71901/19/9910/01/99SE112N8.4For combination therapy with metformin and sulfonylurea in patients with type 2 diabetes.
ACETAMINOPHEN/ ASPIRIN/CAFFEINEBRISTOL MYERS20-80212/18/9810/07/99SE12N9.6Treatment of Migraine
PRAVASTATIN SODIUMBRISTOL MYERS SQUIBB19-89805/25/9910/14/99SE134N4.7Provides 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 HYDROCHLORIDEABBOTT LABS20-63012/16/9810/15/99SE51N10.0For use as an analgesic agent during the maintenance of general anesthesia in pediatric patients for inpatient and outpatient surgery.
ETHINYL ESTRADIOL /NORETHINDRONE ACETATEPARKE DAVIS21-10212/17/9810/15/99N0N9.9For the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis.
PACLITAXELBRISTOL MYERS SQUIBB20-26204/26/9910/25/99SE133Y6.0Provides for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.
NIACINKOS PHARMS20-38112/28/9810/28/99SE16N10.0Provides 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.
DIDANOSINEBRISTOL MYERS SQUIBB20-15404/30/9910/28/99SE229Y6.0Provides 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.
DIDANOSINEBRISTOL MYERS SQUIBB20-15504/30/9910/28/99SE221Y6.0Provides 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.
DIDANOSINEBRISTOL MYERS SQUIBB20-15604/30/9910/28/99SE222Y6.0Provides 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 HYDROCHLORIDEGLAXO WELLCOME18-70312/16/9610/29/99SE856N34.4Provides for labeling revisions regarding use in pediatric patients from 1 month to 16 years of age in response to the Final Rule.
CEFDINIRPARKE DAVIS50-73911/16/9811/08/99SE22N11.7A 5-day dosing regimen (300 mg BID) for the treatment of acute exacerbations of chronic bronchitis.
NICOTINENOVARTIS CONS20-07612/22/9511/12/99SE611N46.7Provides 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 BENZOATEMERCK20-86411/08/9911/16/99SE83N0.3Acute treatment of Migraine
RIZATRIPTAN BENZOATEMERCK20-86501/19/9911/16/99SE81N9.9Acute treatment of Migraine
SIMVASTATINMERCK19-76601/22/9911/22/99SE134N10.0Provides for a new indication for the treatment of patients with isolated hypertriglyceridemia (Frederickson Type IV) .
SIMVASTATINMERCK19-76601/22/9911/22/99SE136N10.0Provides for a new indication for the treatment of Type III hyperlipoproteinemia .
REMIFENTANIL HYDROCHLORIDEABBOTT LABS20-63001/29/9911/23/99SE82N9.8Changes in labeling in response to a Phase 4 commitment to provide additional safety and efficacy data in the cardiac surgery setting.
ALENDRONATE SODIUMMERCK20-56001/28/9911/24/99SE818N9.9Provides 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 SODIUMMERCK20-56009/04/9811/24/99SE815N14.7Provides for the addition to the CLINICAL PHARMACOLOGY section of the labeling the safety and efficacy information for the four-year Fracture Intervention Study.
NELFINAVIR MESYLATEAGOURON20-77801/28/9911/24/99SE211N9.9Provides 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 MESYLATEAGOURON20-77901/28/9911/24/99SE222N9.9Provides 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 INC19-67602/01/9912/01/99SE813N10.0Provides 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, BIOSYNTHETICGENENTECH INC20-52202/01/9912/01/99SE89N10.0Provides 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 CALCIUMWARNER LAMBERT20-70203/04/9912/02/99SE118N9.0Provides 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 MONOHYDRATESCHERING PLOUGH20-76202/02/9912/02/99SE14N10.0Indicated for the treatment of nasal symptoms of seasonal and perennial rhinitis in adults and children 3 years of age and older.
SERTRALINE HYDROCHLORIDEPFIZER PHARMS19-83910/07/9812/07/99SE126N14.0Provides for the additional indication of treatment of Post-traumatic Stress Disorder.
LEVOCARNITINESIGMA TAU20-18202/01/9912/15/99SE16N10.4For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
DOCETAXELRHONE POULENC20-44906/23/9912/23/99SE111Y6.0Treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
CELECOXIBSEARLE21-15606/25/9912/23/99N0Y6.0To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery).
TRAMADOL HYDROCHLORIDEJOHNSON RW20-28102/26/9912/23/99SE216N9.9Management of moderate to moderately severe pain.

 

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