Drug Approvals for February 1997

Definitions and Notes

February 1997

Original New Drug Applications

Original Application #: 020723
Approval Date: 27-FEB-97
Trade Name: ALDARA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): IMIQUIMOD
OTC/RX Status: RX
Indication(s): Treatment of external genital and perianal warts/condyloma acuminata in adults

Original Application #: 020657
Approval Date: 21-FEB-97
Trade Name: SPORANOX
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Indication(s): Treatment of oropharyngeal and esophageal candidiasis

Original Application #: 050734
Approval Date: 17-FEB-97
Trade Name: IDAMYCIN PFS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IDARUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Provides for a liquid formulation (preservative free solution) for IV administration

Original Application #: 020676
Approval Date: 11-FEB-97
Trade Name: VAGISTAT-1
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS PRODUCTS INC
Active Ingredient(s): TIOCONAZOLE
OTC/RX Status: OTC
Indication(s): Provides for the over-the-counter marketing of Vagistat-1 Vaginal Ointment, 6.5%, 1 day vaginal antifungal treatment regimen for the treatment of recurrent vaginal yeast infections (Candidiasis)

Original Application #: 020475
Approval Date: 07-FEB-97
Trade Name: RETIN-A MICRO MICROSPHERE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: ADVANCED POLYMER SYSTEMS INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX
Indication(s): Treatment of acne vulgaris

Original Application #: 019881
Approval Date: 07-FEB-97
Trade Name: FEMSTAT ONE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: EMULSION
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): BUTOCONAZOLE NITRATE
OTC/RX Status: RX
Indication(s): Treatment of vulvovaginal infections caused by Candida albicans

Efficacy Supplemental New Drug Applications

Application #: 050608Efficacy Supplement#:019
Type: SE5 to Original New Drug Application
Approval Date: 12-FEB-97
Trade Name: UNASYN
Dosage Form: INJECTABLE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): AMPICILLIN SODIUM; SULBACTAM SODIUM
OTC/RX Status: RX
Efficacy Claim:Treatment of skin and skin structure infections for pathogens already in the labeling in pediatric patients age 3 months to 12 years old

Approvable Original New Drug Applications

Original Application #: 020707
Approvable Date: 28-FEB-97
Trade Name: SKELID
Dosage Form: TABLET
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): TILUDRONATE DISODIUM
OTC/RX Status: RX

Original Application #: 020617
Approvable Date: 27-FEB-97
Trade Name: PYTEST
Dosage Form: CAPSULE
Applicant: TRI MED SPECIALTIES INC
Active Ingredient(s): UREA C-14
OTC/RX Status: RX

Original Application #: 020710
Approvable Date: 24-FEB-97
Trade Name: PAXIL
Dosage Form: SUSPENSION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020706
Approvable Date: 14-FEB-97
Trade Name: EMADINE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): EMEDASTINE DIFUMARATE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074819
Approval Date: 28-FEB-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074673
Approval Date: 28-FEB-97
Trade Name: GUANFACINE
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): GUANFACINE
OTC/RX Status: RX

Original Abbreviated Application # 040204
Approval Date: 28-FEB-97
Trade Name: DICYCLOMINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: WEST WARD PHARMACEUTICAL INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074789
Approval Date: 27-FEB-97
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: PRIVATE FORMULATIONS INC
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074729
Approval Date: 27-FEB-97
Trade Name: TOLMETIN SODIUM
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): TOLMETIN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074711
Approval Date: 26-FEB-97
Trade Name: MEXILETINE HCL
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): MEXILETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application #064127
Approval Date: 14-FEB-97
Trade Name: ERYTHROMYCIN
Dosage Form: SOLUTION
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX

Original Abbreviated Antibiotic Application #064120
Approval Date: 14-FEB-97
Trade Name: TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
Dosage Form: SOLUTION/DROPS
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): TRIMETHOPRIM SULFATE; POLYMYXIN B SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040148
Approval Date: 14-FEB-97
Trade Name: NORCO
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074868
Approval Date: 12-FEB-97
Trade Name: OXYBUTYNIN CHLORIDE
Dosage Form: SYRUP
Applicant: MORTON GROVE ACQUISITION CORP
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074843
Approval Date: 12-FEB-97
Trade Name: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074836
Tentative Approval Date: 28-FEB-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: ZENITH LABORATORIES INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application #: 074754
Tentative Approval Date: 28-FEB-97
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application #: 074688
Tentative Approval Date: 18-FEB-97
Trade Name: VECURONIUM BROMIDE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): VECURONIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074591
Tentative Approval Date: 11-FEB-97
Trade Name: GLYBURIDE (MICRONIZED)
Dosage Form: TABLET
Applicant: MOVA PHARMACEUTICALS CORP
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #:050581Labeling Supplement#: 020 To Original New Drug Application
Approval Date: 27-FEB-97
Trade Name: MEFOXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX

Application #:050517Labeling Supplement#: 031 To Original New Drug Application
Approval Date: 27-FEB-97
Trade Name: MEFOXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX

Application #:020628Labeling Supplement#: 007 To Original New Drug Application
Approval Date: 27-FEB-97
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX

Application #:019264Labeling Supplement#:019 To Original New Drug Application
Approval Date: 26-FEB-97
Trade Name: PENTAM 300
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): PENTAMIDINE ISETHIONATE
OTC/RX Status: RX

Application #:020406 Labeling Supplement#: 009 To Original New Drug Application
Approval Date: 25-FEB-97
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX

Application #:020685Labeling Supplement#:005
To Original New Drug Application
Approval Date: 19-FEB-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARH LABS
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #:020356Labeling Supplement#:005
To Original New Drug Application
Approval Date: 19-FEB-97
Trade Name: SULAR
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): NISOLDIPINE
OTC/RX Status: RX

Application #:020090Labeling Supplement#:009
To Original New Drug Application
Approval Date: 19-FEB-97
Trade Name: DIFLUCAN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PFIZER
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #:019950Labeling Supplement#:025
To Original New Drug Application
Approval Date: 19-FEB-97
Trade Name: DIFLUCAN
Dosage Form: INJECTABLE
Applicant: PFIZER
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #:019949Labeling Supplement#:024
To Original New Drug Application
Approval Date: 19-FEB-97
Trade Name: DIFLUCAN
Dosage Form: TABLET
Applicant: PFIZER
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #:050682Labeling Supplement#:010
To Original New Drug Application
Approval Date: 18-FEB-97
Trade Name: COSMEGEN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): DACTINOMYCIN
OTC/RX Status: RX

Application #:018150Labeling Supplement#:012
To Original New Drug Application
Approval Date: 18-FEB-97
Trade Name: THALLOUS CHLORIDE TL 201
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT MEDICAL INC
Active Ingredient(s): THALLOUS CHLORIDE, TL-201
OTC/RX Status: RX

Application #:050682Labeling Supplement#:009 To Original New Drug Application
Approval Date: 17-FEB-97
Trade Name: COSMEGEN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): DACTINOMYCIN
OTC/RX Status: RX

Application #:018452Labeling Supplement#:024 To Original New Drug Application
Approval Date: 14-FEB-97
Trade Name: SEPTRA
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX

Application #:020469Labeling Supplement #:003 To Original New Drug Application
Approval Date: 13-FEB-97
Trade Name: VANCENASE AQ
Dosage Form: SPRAY
Applicant: SCHERING CORP
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE MONOHYDRATE
OTC/RX Status: RX

Application #:020469Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 13-FEB-97
Trade Name: VANCENASE AQ
Dosage Form: SPRAY
Applicant: SCHERING CORP
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE MONOHYDRATE
OTC/RX Status: RX

Application #:017598Labeling Supplement#:037 To Original New Drug Application
Approval Date: 13-FEB-97
Trade Name: SEPTRA
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX

Application #:017376Labeling Supplement#:053 To Original New Drug Application
Approval Date: 12-FEB-97
Trade Name: SEPTRA
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX

Application #:019643 LabelingSupplement #:047 To Original New Drug Application
Approval Date: 06-FEB-97
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Application #:019670Labeling Supplement#:004 To Original New Drug Application
Approval Date: 05-FEB-97
Trade Name: CLARITIN-D
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): LORATADINE; PSEUDOEPHEDRINE SULFATE
OTC/RX Status: RX

Application #:020301 LabelingSupplement#: 009 To Original New Drug Application
Approval Date: 04-FEB-97
Trade Name: ORTHO-CEPT
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #:019726 LabelingSupplement#: 019 To Original New Drug Application
Approval Date: 04-FEB-97
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX

Application #:016801 LabelingSupplement#: 033 To Original New Drug Application
Approval Date: 04-FEB-97
Trade Name: XYLOCAINE
Dosage Form: INJECTABLE
Applicant: ASTRA USA, INC
Active Ingredient(s): LIDOCAINE HYDROCHLORIDE
OTC/RX Status: RX