Drug Approvals for June 1999

Definitions and Notes

June 1999

Original New Drug Applications

Original Application #: 020968
Approval Date: 30-JUN-99
Trade Name: MONISTAT DUAL PAK
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUPPOSITORY
Applicant: ADVANCED CARE PRODUCTS
Active Ingredient(s): MICONAZOLE NITRATE
OTC/RX Status: RX
Indication(s): TREATMENT OF VULVOVAGINAL CANDIDIASIS

Original Application #: 020945
Approval Date: 29-JUN-99
Trade Name: NORVIR
Chemical Type:
Therapeutic Potential: S
Dosage Form: CAPSULE, SOFT GELATIN
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX
Indication(s): TO TREAT HIV INFECTION

Efficacy Supplemental New Drug Applications

Application #: 050718 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 28-JUN-99
Trade Name: DOXIL
Dosage Form: INJECTABLE
Applicant: ALZA CORP
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel-and platinum-based chemotherapy regimens

Application #: 020221 Efficacy Supplement#: 012
Type: SE1 to Original New Drug Application
Approval Date: 24-JUN-99
Trade Name: ETHYOL
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCE INC
Active Ingredient(s): AMIFOSTINE
OTC/RX Status: RX
Efficacy Claim: 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

Application #: 019958 Efficacy Supplement#: 008
Type: SE5 to Original New Drug Application
Approval Date: 17-JUN-99
Trade Name: CUTIVATE
Dosage Form: EMULSION, CREAM
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Efficacy Claim: Provides for use in pediatric patients 3 months of age or older with corticosteroid-responsive dermatoses

Application #: 020720 Efficacy Supplement#:012
Type: SE1 to Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: REZULIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Rezulin in combination with metformin and sulfonylurea in patients with type 2 diabetes

Application #: 020560 Efficacy Supplement#: 012
Type: SE1 to Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Efficacy Claim: For the 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

Approvable Original New Drug Applications

Original Application #: 021078
Approvable Date: 30-JUN-99
Trade Name: MALARONE
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ATOVAQUONE; PROGUANIL HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020987
Approvable Date: 30-JUN-99
Trade Name: PROTONIX
Dosage Form: TABLET, DELAYED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX

Original Application #: 020965
Approvable Date: 27-JUN-99
Trade Name: LEVULAN
Dosage Form: SOLUTION
Applicant: GUIDELINES, INCORPORATED
Active Ingredient(s): AMINOLEVULINIC ACID HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020902
Approvable Date: 21-JUN-99
Trade Name: PEPCID AC
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Application #: 020884
Approvable Date: 15-JUN-99
Trade Name: AGGRENOX
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): DIPYRIDAMOLE; ASPIRIN
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075286
Approval Date: 30-JUN-99
Trade Name: PEMOLINE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 075008
Approval Date: 30-JUN-99
Trade Name: FLUOCINONIDE
Dosage Form: OINTMENT
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): FLUOCINONIDE
OTC/RX Status: RX

Original Abbreviated Application # 040332
Approval Date: 28-JUN-99
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Application # 040330
Approval Date: 25-JUN-99
Trade Name: OXYCODINE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): OXYCODINE AND ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 075284
Approval Date: 23-JUN-99
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065015
Approval Date: 22-JUN-99
Trade Name: CEFADROXIL
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): CEFADROXIL
OTC/RX Status: RX

Original Abbreviated Application # 075052
Approval Date: 18-JUN-99
Trade Name: TRIAMTERENE AND HYDROCHLOROTHIZIDE
Dosage Form: CAPSULE
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TRIAMTERENE
OTC/RX Status: RX

Original Abbreviated Application # 075345
Approval Date: 16-JUN-99
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075362
Approval Date: 15-JUN-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075319
Approval Date: 15-JUN-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075314
Approval Date: 15-JUN-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: MUTUAL PHARMACAL CO
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 074971
Approval Date: 15-JUN-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075252
Approval Date: 07-JUN-99
Trade Name: AZATHIOPRINE
Dosage Form: TABLET
Applicant: APPLIED ANALYTICAL INDUSTRIES INC
Active Ingredient(s): AZATHIOPRINE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075300
Tentative Approval Date: 30-JUN-99
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application #: 075269
Tentative Approval Date: 29-JUN-99
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application #: 074681
Tentative Approval Date: 18-JUN-99
Trade Name: FLUCONAZOLE
Dosage Form: TABLET
Applicant: NOVOPHARM NC, INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application #: 075238
Tentative Approval Date: 07-JUN-99
Trade Name: SOTALOL HYDROCHLORIDE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075404
Tentative Approval Date: 04-JUN-99
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075385
Tentative Approval Date: 02-JUN-99
Trade Name: BUSPIRONE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICAL INC
Active Ingredient(s): BUSPIRONE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 050719 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 30-JUN-99
Trade Name: HELIDAC THERAPY
Dosage Form: CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020897 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 22-JUN-99
Trade Name: DITROPAN XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALZA CORPORATION
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX

Application #: 020098 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 25-JUN-99
Trade Name: MIVACRON
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): MIVACURIUM CHLORIDE
OTC/RX Status: RX

Application #: 020088 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 21-JUN-99
Trade Name: NORPLANT SYSTEM
Dosage Form: IMPLANT
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX

Application #: 020897 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 22-JUN-99
Trade Name: DITROPAN XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALZA CORPORATION
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX

Application #: 020895 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 18-JUN-99
Trade Name: VIAGRA
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX

Application #: 020818 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: DIOVAN HCT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #:020364Labeling Supplement#:008
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: LOTREL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): BENAZEPRIL HYDROCHLORIDE; AMLODIPINE BESYLATE
OTC/RX Status: RX

Application #: 019091 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: ISMO
Dosage Form: TABLET
Applicant: A.H. ROBINS COMPANY
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Application #: 018074 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: PHENDIMETRAZINE TARTRATE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: EON LABORATORIES
Active Ingredient(s): PHENDIMETRAZINE TARTRATE
OTC/RX Status: RX

Application #: 012940 Labeling Supplement#: 043
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: ISORDIL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 012093 Labeling Supplement#: 043
To Original New Drug Application
Approval Date: 16-JUN-99
Trade Name: ISORDIL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 011642 Labeling Supplement#: 012
To Original New Drug Application
Permitted Date: 16-JUN-99
Trade Name: CARDIOQUIN
Dosage Form: TABLET
Applicant: PURDUE FREDERICK CO
Active Ingredient(s): QUINIDINE POLYGALACTURONATE
OTC/RX Status: RX

Application #: 020913 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 09-JUN-99
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 09-JUN-99
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020387 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 09-JUN-99
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020386 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 09-JUN-99
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 #: 007529 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 09-JUN-99
Trade Name: QUINIDINE GLUCONATE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): QUINIDINE GLUCONATE
OTC/RX Status: RX

Application #: 020560 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 08-JUN-99
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): ALEDRONATE SODIUM
OTC/RX Status: RX

Application #: 004782 Labeling Supplement#: 109
To Original New Drug Application
Approval Date: 08-JUN-99
Trade Name: PREMARIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): CONJUGATED, ESTROGENS
OTC/RX Status: RX

Application #: 020946 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 07-JUN-99
Trade Name: PREVEN EMERGENCY CONTRACEPTIVE KIT
Dosage Form: TABLET
Applicant: GYNETICS INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019614 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 05-JUN-99
Trade Name: VERELAN
Dosage Form: CAPSULE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018826 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 05-JUN-99
Trade Name: DOPAMINE HYDROCHLORIDE
Dosage Form: INJECTABLE IN FLEXIBLE CONTAINER
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020943 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: VERELAN PM
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020655 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 04-JUN-99
Trade Name: ALORA
Dosage Form: FILM, EXTENDED RELEASE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX