Drug Approvals for June 1998

Definitions and Notes

June 1998

Original New Drug Applications

Original Application #: 020865
Approval Date: 29-JUN-98
Trade Name: MAXALT - MLTRAPIDISC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Indication(s): Acute treatment of migraine headache

Original Application #: 020864
Approval Date: 29-JUN-98
Trade Name: MAXALT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Indication(s): Acute treatment of migraine headache

Original Application #: 021024
Approval Date: 22-JUN-98
Trade Name: PRIFTIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): RIFAPENTINE
OTC/RX Status: RX
Indication(s): Treatment of pulmonary tuberculosis

Original Application #: 019832
Approval Date: 05-JUN-98
Trade Name: SULFAMYLON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): MAFENIDE ACETATE
OTC/RX Status: RX
Indication(s):Adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds

Original Application #: 020838
Approval Date: 04-JUN-98
Trade Name: ATACAND
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ASTRA MERCK GROUP
Active Ingredient(s): CANDESARTAN CILEXETIL
OTC/RX Status: RX
Indication(s): TREATMENT OF HYPERTENSION

Original Application #: 020903
Approval Date: 03-JUN-98
Trade Name: INTRON A/REBETOL
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: INJECTABLE/CAPSULE
Applicant: SCHERING CORP
Active Ingredient(s): INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRIN
OTC/RX Status: RX
Indication(s): Treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy

Efficacy Supplemental New Drug Applications

Application #: 018603 Efficacy Supplement #: 019
Type: SE1 to Original New Drug Application
Approval Date: 02-JUN-98
Trade Name: ZOVIRAX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX
Efficacy Claim: Treatment of herpes simplex virus infections in neonatal patients

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075227
Approval Date: 30-JUN-98
Trade Name: NAPROXEN
Dosage Form: TABLET, DELAYED RELEASE
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX

Original Abbreviated Application # 064210
Approval Date: 30-JUN-98
Trade Name: STREPTOMYCIN SULFATE
Dosage Form: INJECTABLE
Applicant: PHARMA TEK INC
Active Ingredient(s): STREPTOMYCIN SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040272
Approval Date: 30-JUN-98
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE
OTC/RX Status: RX

Original Abbreviated Application #: 075122
Tentative Approval Date: 19-JUN-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: LEK USA INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 074972
Approval Date: 19-JUN-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 074963
Approval Date: 19-JUN-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: PHARMACEUTICAL FORMULATIONS INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 074961
Approval Date: 19-JUN-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 074948
Approval Date: 19-JUN-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 074873
Approval Date: 19-JUN-98
Trade Name: TRETINOIN
Dosage Form: SOLUTION
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Abbreviated Application # 040284
Approval Date: 19-JUN-98
Trade Name: ORPHENADRINE CITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: INVAMED INC
Active Ingredient(s): ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application #: 075110
Tentative Approval Date: 18-JUN-98
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075055
Approval Date: 18-JUN-98
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075050
Approval Date: 18-JUN-98
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 074415
Approval Date: 08-JUN-98
Trade Name: SUCRALFATE
Dosage Form: TABLET
Applicant: MARTEC PHARMACEUTICAL
Active Ingredient(s): SUCRALFATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074816
Tentative Approval Date: 08-JUN-98
Trade Name: PROPOFOL
Dosage Form: EMULSION, INJECTION
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): PROPOFOL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 019766 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 29-JUN-98
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK & CO INC
Active Ingredient(s): SIMVASTATIN

Application #: 012845 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 24-JUN-98
Trade Name: RENESE
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): POLYTHIAZIDE
OTC/RX Status: RX

Application #: 012796 Labeling Supplement #: 048
To Original New Drug Application
Approval Date: 24-JUN-98
Trade Name: QUINIDEX
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH AYERST RESEARCH
Active Ingredient(s): QUINIDINE SULFATE
OTC/RX Status: RX

Application #: 020417 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 17-JUN-98
Trade Name: FEMPATCH
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 009402 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 17-JUN-98
Trade Name: DELESTROGEN
Dosage Form: INJECTABLE
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): ESTRADIOL VALERATE
OTC/RX Status: RX

Application #: 050686 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 15-JUN-98
Trade Name: CEDAX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN DIHYDRATE
OTC/RX Status: RX

Application #: 007529 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 15-JUN-98
Trade Name: QUINIDINE GLUCONATE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): QUINIDINE GLUCONATE
OTC/RX Status: RX

Application #: 020516 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 04-JUN-98
Trade Name: CHILDREN'S MOTRIN
Dosage Form: SUSPENSION
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 018709 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 03-JUN-98
Trade Name: CAPOZIDE 25/15; 50/15; 25/25; 50/25
Dosage Form: TABLET
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 009218 Labeling Supplement #: 091
To Original New Drug Application
Approval Date: 01-JUN-98
Trade Name: COUMADIN
Dosage Form: TABLET AND INJECTABLE
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX

Application #: 009218 Labeling Supplement #: 090
To Original New Drug Application
Approval Date: 01-JUN-98
Trade Name: COUMADIN
Dosage Form: TABLET AND INJECTABLE
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX

Application #: 009218 Labeling Supplement #: 086
To Original New Drug Application
Approval Date: 01-JUN-98
Trade Name: COUMADIN
Dosage Form: TABLET AND INJECTABLE
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX