Drug Approvals for September 1999

Definitions and Notes

Original New Drug Applications

Original Application #: 021079
Approval Date: 24-SEP-99
Trade Name:ALAMAST
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: SANTEN INC
Active Ingredient(s): PEMIROLAST POTASSIUM
OTC/RX Status: RX
Indication(s): For the prevention of itching of the eye due to allergic conjunctivitis

Original Application #: 050748
Approval Date: 21-SEP-99
Trade Name: SYNERCID
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): DALFOPRISTIN; QUINUPRISTIN
OTC/RX Status: RX
Indication(s): For the treatment of complicated skin and skin structure infections

Original Application #: 050747
Approval Date: 21-SEP-99
Trade Name: SYNERCID
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): DALFOPRISTIN; QUINUPRISTIN
OTC/RX Status: RX
Indication(s): For the treatment of vancomycin resistant Enterococcus faecium

Original Application #: 020793
Approval Date: 21-SEP-99
Trade Name: CAFCIT
Chemical Type: 2
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: OREAD PEDIATRIC ROXANE DEVELOPMENT LTD PARTNERSHIP
Active Ingredient(s): CAFFEINE
OTC/RX Status: RX
Indication(s):For the short term treatment of apnea of prematurity in infants between 28 and 33 weeks gestational age

Original Application #: 021048
Approval Date: 20-SEP-99
Trade Name:ESTRADIOL TRANSDERMAL SYSTEM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: PATCH, CONTROLLED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): For the treatment of moderate to severe vasomotor symptoms associated with the menopause and treatment of vulvar and vaginal atrophy

Original Application #: 021083
Approval Date: 15-SEP-99
Trade Name: RAPAMUNE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): SIROLIMUS
OTC/RX Status: RX
Indication(s): For the prophylaxis of organ rejection in patients receiving renal transplants

Original Application #: 050778
Approval Date: 15-SEP-99
Trade Name: ELLENCE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: PHARMACIA & UPJOHN COMPANY
Active Ingredient(s): EPIRUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer

Efficacy Supplemental New Drug Applications

Application #: 020815 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 30-SEP-99
Trade Name: EVISTA
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): RALOXIFENE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of osteoporosis in postmenopausal women

Application #: 020718 Efficacy Supplement#: 002
Type: SE8 to Original New Drug Application
Approval Date: 20-SEP-99
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS, INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with acute coronary syndrome (US/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).

Application #:020547Efficacy Supplement#:007
Type: SE1 to Original New Drug Application
Approval Date: 17-SEP-99
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis and chronic treatment of asthma in pdiatric patients 7-11 years of age

Application #: 20711 Efficacy Supplement#: 003
Type: SE2 to Original New Drug Application
Approval Date: 10-SEP-99
Trade Name: ZYBAN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For use as an aid to smoking cessation

Application #: 20711 Efficacy Supplement#: 001
Type: SE2 to Original New Drug Application
Approval Date: 10-SEP-99
Trade Name: ZYBAN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For use as an aid to smoking cessation

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075375
Approval Date: 30-SEP-99
Trade Name: DILTIAZEM HCL
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075242
Approval Date: 30-SEP-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075091
Approval Date: 30-SEP-99
Trade Name: CARBIDOPA AND LEVODOPA
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICAL
Active Ingredient(s): CARBIDOPA AND LEVODOPA
OTC/RX Status: RX

Original Abbreviated Application # 040251
Approval Date: 27-SEP-99
Trade Name: TRIHEXYPHENIDYL HCL
Dosage Form: LIQUID
Applicant: MIKART INC
Active Ingredient(s): TRIHEXYPHENIDYL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075126
Approval Date: 16-SEP-99
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: NOVOPHARM LTD
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 065007
Approval Date: 16-SEP-99
Trade Name: CEPHALEXIN
Dosage Form: CAPSULE
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): CEPHALEXIN
OTC/RX Status: RX

Original Abbreviated Application # 074845
Approval Date: 15-SEP-99
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL RESEARCH CORP
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075161
Approval Date: 13-SEP-99
Trade Name: TICLOPIDINE HCL
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040319
Approval Date: 07-SEP-99
Trade Name: DICYCLOMINE HCL
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040317
Approval Date: 07-SEP-99
Trade Name: DICYCLOMIDE HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075493
Approval Date: 01-SEP-99
Trade Name: VINCRISTINE SULFATE
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): VINCRISTINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075199
Approval Date: 03-SEP-99
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075551
Tentative Approval Date: 30-SEP-99
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application #: 075249
Tentative Approval Date: 30-SEP-99
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075247
Tentative Approval Date: 30-SEP-99
Trade Name: MIDAZOLAM HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075455
Tentative Approval Date: 17-SEP-99
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075011
Tentative Approval Date: 17-SEP-99
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 017037 Labeling Supplement#: 136
To Original New Drug Application
Approval Date: 30-SEP-99
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 020005 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 29-SEP-99
Trade Name: CARDENE SR
Dosage Form: CAPSULE
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020164 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 28-SEP-99
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #: 012649 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 24-SEP-99
Trade Name: PERIACTIN
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): CYPROHEPTADINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020847 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 27-SEP-99
Trade Name: ESCLIM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: FOURNIER RESEARCH INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 021039 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 22-SEP-99
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 021007 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 22-SEP-99
Trade Name: AGENERASE
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 020304 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 21-SEP-99
Trade Name: TRASYLOL
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): APROTININ BOVINE
OTC/RX Status: RX

Application #: 007513 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 20-SEP-99
Trade Name: LEVOPHED
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): NOREPINEPHRINE BITARTRATE
OTC/RX Status: RX

Application #: 020695 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 15-SEP-99
Trade Name: RAXAR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): GREPAFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019766 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 15-SEP-99
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 004570 Labeling Supplement#: 055
To Original New Drug Application
Approval Date: 15-SEP-99
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 015230 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 14-SEP-99
Trade Name: AMICAR
Dosage Form: SYRUP
Applicant: IMMUNEX CORPORATION
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX

Application #: 020338 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 10-SEP-99
Trade Name: DIFFERIN
Dosage Form: SOLUTION
Applicant: GALDERMA LABORATORIES
Active Ingredient(s): ADAPALENE
OTC/RX Status: RX

Application #: 020221 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 10-SEP-99
Trade Name: ETHYOL
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCES INC
Active Ingredient(s): AMIFOSTINE
OTC/RX Status: RX

Application #: 020049 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 10-SEP-99
Trade Name: PENTASA
Dosage Form: CAPSULE
Applicant: ROBERTS LABORATORIES INC
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 019281 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-SEP-99
Trade Name: CYKLOKAPRON
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRANEXAMIC ACID
OTC/RX Status: RX

Application #: 019280 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 09-SEP-99
Trade Name: CYKLOKAPRON
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRANEXAMIC ACID
OTC/RX Status: RX

Application #: 020297 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 08-SEP-99
Trade Name: COREG
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CARVEDILOL
OTC/RX Status: RX

Application #: 020667 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 03-SEP-99
Trade Name: MIRAPEX
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): PRAMIPEXOLE DIHYDROCHLORIDE
OTC/RX Status: RX

Application #: 018168 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 02-SEP-99
Trade Name: DEMULEN 1/35-21
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 018160 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 02-SEP-99
Trade Name: DEMULEN 1/35-28
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016936 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 02-SEP-99
Trade Name: DEMULEN 1/50-28
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016927 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 02-SEP-99
Trade Name: DEMULEN 1/50-21
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): ETHYNODIOL DIACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020201 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 01-SEP-99
Trade Name: DOBUTAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX