Drug Approvals for May 1998

Definitions and Notes

May 1998

Original New Drug Applications

Original Application #: 020718
Approval Date: 18-MAY-98
Trade Name: INTEGRILIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX
Indication(s): Treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction; Treatment of patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention

Original Application #: 020774
Approval Date: 15-MAY-98
Trade Name: PERIO CHIP
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CHIP
Applicant: PERIO PRODUCTS LTD
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX
Indication(s): Adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis

Original Application #: 020913
Approval Date: 14-MAY-98
Trade Name: AGGRASTAT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Use in combination with HEPARIN, for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy

Original Application #: 020912
Approval Date: 14-MAY-98
Trade Name: AGGRASTAT
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Use in combination with HEPARIN, for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing PTCA or atherectomy

Original Application #: 019781
Approval Date: 14-MAY-98
Trade Name: PROMETRIUM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Indication(s): Treatment of secondary amenorrhea in premenopausal women

Original Application #: 020809
Approval Date: 04-MAY-98
Trade Name: DICLOFENAC SODIUM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX
Indication(s): Treatment of postoperative inflammation in patients who have undergone cataract extration

Efficacy Supplemental New Drug Applications

Application #: 020636 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 20-MAY-98
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Efficacy Claim: Provides for a change in the indication as follows: “Viramune is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection”

Application #: 020346 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 15-MAY-98
Trade Name: ZYRTEC
Dosage Form: SYRUP
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Use in pediatric patients 2 to 5 years of age for the indications seasonal and perennial allergic rhinitis and chronic idiopathic urticaria

Application #: 019835 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 15-MAY-98
Trade Name: ZYRTEC
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): CETIRIZINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Use in pediatric patients 2 to 5 years of age for the indications seasonal and perennial allergic rhinitis and chronic idiopathic urticaria

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075141
Approval Date: 29-MAY-98
Trade Name: ORPHENGESIC FORTE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
OTC/RX Status: RX

Original Abbreviated Application # 040274
Approval Date: 29-MAY-98
Trade Name: HYDROXYCHLOROQINE SULFATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): HYDROXYCHLOROQUINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040241
Approval Date: 29-MAY-98
Trade Name: METHADONE HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): METHADONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040213
Approval Date: 29-MAY-98
Trade Name: THIORIDAZINE HCL
Dosage Form: CONCENTRATE
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): THIORIDAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074464
Approval Date: 28-MAY-98
Trade Name: INDOMETHACIN
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Original Abbreviated Application # 040192
Approval Date: 28-MAY-98
Trade Name: PRE-PRED
Dosage Form: SYRUP
Applicant: WE PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Application # 074404
Approval Date: 14-MAY-98
Trade Name: ATENOLOL AND CHLORTHALIDONE
Dosage Form: TABLET
Applicant: MARTEC PHARMACEUTICALS INC
Active Ingredient(s): ATENOLOL; CHLORTHALIDONE
OTC/RX Status: RX

Original Abbreviated Application # 074930
Approval Date: 13-MAY-98
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074918
Approval Date: 08-MAY-98
Trade Name: NALTREXONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): NALTREXONE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075122
Tentative Approval Date: 28-MAY-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: LEK PHARMACEUTICAL AND CHEMICAL CO DD
Active Ingredient(s): CIMETIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074961
Tentative Approval Date: 28-MAY-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): CIMETIDINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 010402 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 29-MAY-98
Trade Name: PREMARIN
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED
OTC/RX Status: RX

Application #: 020579 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 26-MAY-98
Trade Name: FLOMAX
Dosage Form: CAPSULE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): TAMSULOSIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020692 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-MAY-98
Trade Name: SEREVENT DISKUS
Dosage Form: POWDER, FOR INHALATION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 018731 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 20-MAY-98
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018731 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 20-MAY-98
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017473 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 20-MAY-98
Trade Name: ORAP
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): PIMOZIDE
OTC/RX Status: RX

Application #: 020098 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 19-MAY-98
Trade Name: MIVACRON
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): MIVACURIUM CHLORIDE
OTC/RX Status: RX

Application #: 018061 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 15-MAY-98
Trade Name: TIMOLIDE 10-25
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TIMOLOLMALEATE
OTC/RX Status: RX

Application #: 018017 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 15-MAY-98
Trade Name: BLOCADREN
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020756 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 11-MAY-98
Trade Name: CRINONE
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX

Application #: 020701 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-MAY-98
Trade Name: CRINONE
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX

Application #: 020236 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-MAY-98
Trade Name: SEREVENT
Dosage Form: AEROSOL
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 017989 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 11-MAY-98
Trade Name: HEMABATE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CARBOPROST TROMETHAMINE
OTC/RX Status: RX

Application #: 019888 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 08-MAY-98
Trade Name: ZESTORETIC
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX

Application #: 019297 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 08-MAY-98
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE
OTC/RX Status: RX

Application #: 019059 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 08-MAY-98
Trade Name: INDERIDE LA 80/50; 120/50; 160/50
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 004782 Labeling Supplement#: 104
To Original New Drug Application
Approval Date: 06-MAY-98
Trade Name: PREMARIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED
OTC/RX Status: RX

Application #: 004782 Labeling Supplement#: 096
To Original New Drug Application
Approval Date: 06-MAY-98
Trade Name: PREMARIN
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ESTROGENS, CONJUGATED
OTC/RX Status: RX

Application #: 019777 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 01-MAY-98
Trade Name: ZESTRIL
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX