Drug Approvals for November 1997

Definitions and Notes

November 1997

Original New Drug Applications

Original Application #: 020652
Approval Date: 26-NOV-97
Trade Name: TESLASCAN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): MANGAFODIPIR TRISODIUM
OTC/RX Status: RX
Indication(s): As an adjunct to MRI to enhance the T1-weighted images used in the detection, localization, characterization, and evaluation of lesions of the liver

Original Application #: 020768
Approval Date: 25-NOV-97
Trade Name: ZOMIG
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZOLMITRIPTAN
OTC/RX Status: RX
Indication(s): Treatment of migraine headaches

Original Application #: 020632
Approval Date: 22-NOV-97
Trade Name: MERIDIA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): SIBUTRAMINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet

Original Application #: 020839
Approval Date: 17-NOV-97
Trade Name: PLAVIX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): CLOPIDOGREL BISULFATE
OTC/RX Status: RX
Indication(s): For the reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease

Original Application #: 020834
Approval Date: 14-NOV-97
Trade Name: ROGAINE EXTRA STRENGTH FOR MEN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MINOXIDIL
OTC/RX Status: RX
Indication(s): For hair regrowth treatment for men

Original Application #: 020767
Approval Date: 07-NOV-97
Trade Name: PROPULSID QUICKSOLV
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE MONOHYDRATE
OTC/RX Status: RX
Indication(s): Symptomatic treatment of patients with nocturnal heartburn due to gastroesophageal reflux disease

Original Application #: 020695
Approval Date: 06-NOV-97
Trade Name: RAXAR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): GREPAFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Provides for the indications of acute bacterial exacerbations of chronic bronchitis, community-acquired pneumonia, uncomplicated gonorrhea (urethral in males and endocervial and rectal in females), and nongonococcal urethritis and cervicitis

Original Application #: 020811
Approval Date: 03-NOV-97
Trade Name: ACULAR PF
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Indication(s): For use in the reduction of ocular pain and photophobia following incisional refractive surgery

Efficacy Supplemental New Drug Applications

Application #:020524 Efficacy Supplement#:001
Type: SE2 to Original New Drug Application
Approval Date: 25-NOV-97
Trade Name: MENTAX CREAM
Applicant: PENEDERM INC
Active Ingredient(s): BUTENAFINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For a one week dosing of interdigital tinea pedis

Application #:020121 Efficacy Supplement#:005
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients 4 to 11 years of age for the management of the nasal symptoms of seasonal and perennial allergic rhinitis

Application #:020524 Efficacy Supplement#:001
Type: SE2 to Original New Drug Application
Approval Date: 25-NOV-97
Trade Name: MENTAX CREAM
Applicant: PENEDERM INC
Active Ingredient(s): BUTENAFINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For a one week dosing of interdigital tinea pedis

Application #:020121 Efficacy Supplement#:005
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: FLONASE
Dosage Form: SPRAY, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients 4 to 11 years of age for the management of the nasal symptoms of seasonal and perennial allergic rhinitis

Approvable Original New Drug Applications

Original Application #: 020427
Approvable Date: 26-NOV-97
Trade Name: SABRIL
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): VIGABATRIN
OTC/RX Status: RX

Original Application #: 020774
Approvable Date: 25-NOV-97
Trade Name: PERIO CHIP
Dosage Form: DOSAGE FORM NOT GIVEN
Applicant: PERIO PRODUCTS LTD
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX 11/28/97

Original Application #: 020772
Approvable Date: 06-NOV-97
Trade Name: SUCRAID
Dosage Form: SOLUTION
Applicant: ORPHAN MEDICAL INC
Active Ingredient(s): SACROSIDASE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075009
Approval Date: 26-NOV-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074952
Approval Date: 26-NOV-97
Trade Name: DIPYRIDAMOLE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX

Original Abbreviated Application # 074949
Approval Date: 26-NOV-97
Trade Name: CLOZAPINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Original Abbreviated Application # 074914
Approval Date: 26-NOV-97
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074866
Approval Date: 26-NOV-97
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicant: ALPHAPHARM PARTY LTD
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074579
Approval Date: 26-NOV-97
Trade Name: BETAMETHASONE DIPROPIONATE
Dosage Form: CREAM
Applicant: CLAY PARK LABORATORIES INC
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 074252
Approval Date: 26-NOV-97
Trade Name: CIMETIDINE HCL
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040240
Approval Date: 26-NOV-97
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 040039
Approval Date: 26-NOV-97
Trade Name: TRIAMCINOLONE ACETONIDE
Dosage Form: CREAM
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): TRIAMCINOLONE
OTC/RX Status: RX

Original Abbreviated Application # 074946
Approval Date: 19-NOV-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: AESGEN INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074613
Approval Date: 18-NOV-97
Trade Name: BUMETANIDE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): BUMETANIDE
OTC/RX Status: RX

Original Abbreviated Application # 040223
Approval Date: 18-NOV-97
Trade Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval

Original Abbreviated Application #: 074788
Tentative Approval Date: 26-NOV-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075022
Tentative Approval Date: 25-NOV-97
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074794
Tentative Approval Date: 18-NOV-97
Trade Name: RANITIDINE
Dosage Form: SOLUTION
Applicant: PHARMADYNE CORP
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 016709 Labeling Supplement#: 122
To Original New Drug Application
Approval Date: 28-NOV-97
Trade Name: ORTHO-NOVUM 1/50 28
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; MESTRANOL
OTC/RX Status: RX

Application #:012728 Labeling Supplement#: 187
To Original New Drug Application
Approval Date: 28-NOV-97
Trade Name: ORTHO-NOVUM 1/50 21
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): NORETHINDRONE; MESTRANOL
OTC/RX Status: RX

Application #: 012541 Labeling Supplement#: 067
To Original New Drug Application
Approval Date: 28-NOV-97
Trade Name: DEPO-PROVERA
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Application #:020236 Labeling Supplement#:014
To Original New Drug Application
Approval Date: 26-NOV-97
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #:020058 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 26-NOV-97
Trade Name: THIOPLEX
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): THIOTEPA
OTC/RX Status: RX

Application #: 016954 Labeling Supplement#: 083
To Original New Drug Application
Approval Date: 25-NOV-97
Trade Name: MICRONOR
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMA RES INSTITUTE
Active Ingredient(s): NORETHINDRONE
OTC/RX Status: RX

Application #: 020497 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 20-NOV-97
Trade Name: FARESTON
Dosage Form: TABLET
Applicant: ORION CORP
Active Ingredient(s): TOREMIFENE CITRATE
OTC/RX Status: RX

Application #: 020281 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 20-NOV-97
Trade Name: ULTRAM
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020281 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 20-NOV-97
Trade Name: ULTRAM
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019661 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 14-NOV-97
Trade Name: CYTOVENE IV
Dosage Form: INJECTABLE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): GANCICLOVIR SODIUM
OTC/RX Status: RX

Application #: 012616 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 13-NOV-97
Trade Name: ALDACTAZIDE
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
OTC/RX Status: RX

Application #: 012616 Labeling Supplement#: 058
To Original New Drug Application
Approval Date: 13-NOV-97
Trade Name: ALDACTAZIDE
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
OTC/RX Status: RX

Application #: 018473 Labeling Supplement#:027
To Original New Drug Application
Approval Date: 12-NOV-97
Trade Name: VENTOLIN
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX

Application #: 020398 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: PROPULSID
Dosage Form: SUSPENSION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE
OTC/RX Status: RX

Application #: 020387 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 020386 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 020210 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: PROPULSID
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE
OTC/RX Status: RX

Application #: 018917 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: SECTRAL
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ACEBUTOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018553 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: INDERAL LA
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018303 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: LOPRESSOR HCT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
OTC/RX Status: RX

Application #: 018031 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: INDERIDE-40/25
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018031 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: INDERIDE-80/25
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 016419 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: INDERAL
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016418 Labeling Supplement#: 070
To Original New Drug Application
Approval Date: 07-NOV-97
Trade Name: INDERAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020357 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 06-NOV-97
Trade Name: GLUCOPHAGE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020702 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 05-NOV-97
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX

Application #: 020306 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 05-NOV-97
Trade Name: FLUDEOXYGLUCOSE F18
Dosage Form: INJECTABLE
Applicant: DOWNSTATE CLINICAL PET CENTER
Active Ingredient(s): FLUDEOXYGLUCOSE, F-18
OTC/RX Status: RX

Application #: 019810 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 04-NOV-97
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE PELLETS
Applicant: ASTRA MERCK INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Application #: 019779 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 03-NOV-97
Trade Name: IOPIDINE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES
Active Ingredient(s): APRACLONIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016093 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 03-NOV-97
Trade Name: EDECRIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): ETHACRYNATE SODIUM
OTC/RX Status: RX

Application #: 016092 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 03-NOV-97
Trade Name: EDECRIN
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): ETHACRYNIC ACID
OTC/RX Status: RX