Drug Approvals for August 1998

Definitions and Notes

August 1998

Original New Drug Applications

Original Application #: 020961
Approval Date: 26-AUG-98
Trade Name: VITRAVENE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: ISIS PHARMACEUTICALS INC
Active Ingredient(s): FOMIVIRSEN SODIUM
OTC/RX Status: RX
Indication(s): Local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis

Original Application #: 020849
Approval Date: 26-AUG-98
Trade Name: PROSOL 20% IN PLASTIC CONTAINER
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS
OTC/RX Status: RX
Indication(s): (1) As an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: the alimentary tract cannot or should not be used; gastrointestinal absorption of protein is impaired; or metabolic requirements for protein are substantially increased, as with extensive burns; (2) To reduce fluid intake in patients who require both fluid restriction and total parenteral nutrition (TPN)

Original Application #: 020764
Approval Date: 24-AUG-98
Trade Name: LAMICTAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET,CHEWABLE DISPERSIBLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX
Indication(s): Provides bioequivalency data to support a new dosage form of lamotrigine, and clinical data to support a new indication for the use of lamotrigine, as compared to the already approved Lamictal Tablet. Specifically, the new indication is for the use of lamotrigine for adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients

Original Application #: 020870
Approval Date: 07-AUG-98
Trade Name: COMBIPATCH
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX
Indication(s): Treatment, in women with a uterus, of: 1. Moderate-to-severe vasomotor symptoms associated with menopause; 2. Vulvar and vaginal atrophy; and 3. Hypoestrogenism due to hypogonadism, castration or primary ovarian failure

Original Application #: 020847
Approval Date: 04-AUG-98
Trade Name: ESCLIM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: FOURNIER RESEARCH INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): Treatment of: 1. Moderate to severe vasomotor symptoms associated with menopause; 2. Vulval and vaginal atrophy; and 3. Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure

Efficacy Supplemental New Drug Applications

Application #: 020304 Efficacy Supplement #: 004
Type: SE1 to Original New Drug Application
Approval Date: 28-AUG-98
Trade Name: TRASYLOL
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): APROTININ BOVINE
OTC/RX Status: RX
Efficacy Claim: Prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery

Application #: 020509 Efficacy Supplement #: 005
Type: SE1 to Original New Drug Application
Approval Date: 25-AUG-98
Trade Name: GEMZAR
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GEMCITABINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Provides for the use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stave IV) non-small cell lung cancer

Application #: 020241 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 24-AUG-98
Trade Name: LAMICTAL
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX
Efficacy Claim: Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients

Application #: 011961 Efficacy Supplement #: 017
Type: SE1 to Original New Drug Application
Approval Date: 18-AUG-98
Trade Name: MARPLAN
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ISOCARBOXAZID
OTC/RX Status: RX
Efficacy Claim: Provides for safety and efficacy data in support of a claim for the effectiveness of Marplan as a second line treatment of depression

Application #: 011839 Efficacy Supplement #: 068
Type: SE1 to Original New Drug Application
Approval Date: 04-AUG-98
Trade Name: PROVERA
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX
Efficacy Claim: For the reduction of endometrial hyperplasia in postmenopausal women receiving 0.625mg conjugated estrogens for 12 to 14 consecutive days per month, either beginning on the 1st day of the cycle or the 16th day of the cycle.

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074951
Approval Date: 31-AUG-98
Trade Name: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form: CAPSULE
Applicant: JEROME STEVENS PHARMACEUTICALS INC
Active Ingredient(s): ASPIRIN; BUTALBITAL; CAFFEINE; AND CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 040206
Approval Date: 28-AUG-98
Trade Name: DIGOXIN
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DIGOXIN
OTC/RX Status: RX

Original Abbreviated Application # 075042
Approval Date: 25-AUG-98
Trade Name: HYDROCORTISONE
Dosage Form: CREAM
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): HYDROCORTISONE VALERATE
OTC/RX Status: RX

Original Abbreviated Application # 075259
Approval Date: 27-AUG-98
Trade Name: DACARBAZINE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): DACARBAZINE
OTC/RX Status: RX

Original Abbreviated Application # 075043
Approval Date: 25-AUG-98
Trade Name: HYDROCORTISONE VALERATE
Dosage Form: OINTMENT
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): HYDROCORTISONE VALERATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 064169
Approval Date: 14-AUG-98
Trade Name: CEFAZOLIN SODIUM
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075057
Approval Date: 12-AUG-98
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: OINTMENT
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 075046
Approval Date: 12-AUG-98
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 075045
Approval Date: 12-AUG-98
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074489
Approval Date: 12-AUG-98
Trade Name: HYDROCORTISONE VALERATE
Dosage Form: CREAM
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): HYDROCORTISONE VALERATE
OTC/RX Status: RX

Original Abbreviated Application # 075219
Approval Date: 06-AUG-98
Trade Name: DICLOFENAC POTASSIUM
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX

Original Abbreviated Application # 074943
Approval Date: 06-AUG-98
Trade Name: DILTIAZEM HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: TORPHARM INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075113
Approval Date: 04-AUG-98
Trade Name: LABETALOL HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074920
Approval Date: 04-AUG-98
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 074728
Approval Date: 04-AUG-98
Trade Name: LEUPROLIDE ACETATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 040257
Approval Date: 04-AUG-98
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: MALLINCKRODT CHEMICAL INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075133
Approval Date: 03-AUG-98
Trade Name: LABETALOL HCL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074787
Approval Date: 03-AUG-98
Trade Name: LABETALOL HCL
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074616
Approval Date: 03-AUG-98
Trade Name: AMRINONE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): AMRINONE LACTATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075132
Tentative Approval Date: 24-AUG-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074530
Tentative Approval Date: 14-AUG-98
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075280
Tentative Approval Date: 06-AUG-98
Trade Name: NABUMETONE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020758 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 31-AUG-98
Trade Name: AVAPRO HCT
Dosage Form: TABLET
Applicant: BRISTOL-MYERS SQUIBB
Active Ingredient(s): HYDROCHLOROTHIAZIDE; IRBESARTAN
OTC/RX Status: RX

Application #: 020386 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 31-AUG-98
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 #: 020386 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 31-AUG-98
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 #: 020386 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 31-AUG-98
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 #: 018473 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 31-AUG-98
Trade Name: VENTOLIN
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX

Application #: 020702 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 28-AUG-98
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: WARNER LAMBERT EXPORT LTD
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX

Application #: 020199 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 28-AUG-98
Trade Name: HIVID
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ZALCITABINE
OTC/RX Status: RX

Application #: 019643 Labeling Supplement #: 056
To Original New Drug Application
Approval Date: 28-AUG-98
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Application #: 020387 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 25-AUG-98
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 018916 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 25-AUG-98
Trade Name: HEPARIN SODIUM IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 020387 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 24-AUG-98
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 018201 Labeling Supplement #: 034
To Original New Drug Application
Approval Date: 24-AUG-98
Trade Name: MODURETIC 5-50
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 019758 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 19-AUG-98
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #: 020690 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 18-AUG-98
Trade Name: ARICEPT
Dosage Form: TABLET
Applicant: EISAI INC
Active Ingredient(s): DONEPEZIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020767 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: PROPULSID QUICKSOLV
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE MONOHYDRATE
OTC/RX Status: RX

Application #: 020547 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX

Application #: 020398 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: PROPULSID
Dosage Form: SUSPENSION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE MONOHYDRATE
OTC/RX Status: RX

Application #: 020210 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: PROPULSID
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE MONOHYDRATE
OTC/RX Status: RX

Application #: 019898 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX

Application #: 018938 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 17-AUG-98
Trade Name: DDAVP
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): DESMOPRESSIN ACETATE
OTC/RX Status: RX

Application #: 020895 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 13-AUG-98
Trade Name: VIAGRA
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX

Application #: 019425 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 13-AUG-98
Trade Name: TRANDATE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018716 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 13-AUG-98
Trade Name: TRANDATE
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020246 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 12-AUG-98
Trade Name: DEPO-PROVERA
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Application #: 018127 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 10-AUG-98
Trade Name: OVCON-35
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE
OTC/RX Status: RX

Application #: 017716 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 10-AUG-98
Trade Name: OVCON-35
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE
OTC/RX Status: RX

Application #: 017576 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 10-AUG-98
Trade Name: OVCON-50
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020408 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: TRUSOPT
Dosage Form: SOLUTION/DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012813 Labeling Supplement #: 043
To Original New Drug Application
Approval Date: 03-AUG-98
Trade Name: BLEPHAMIDE
Dosage Form: SUSPENSION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
OTC/RX Status: RX