Drug Approvals for October 1998

Definitions and Notes

October 1998

Original New Drug Applications

Original Application #: 020926
Approval Date: 30-OCT-98
Trade Name: RENAGEL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: GELTEX PHARMACEUTICALS INC
Active Ingredient(s): SEVELAMER HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the reduction of serum phosphorus in patients with end stage renal disease who are on hemodialysis

Original Application #: 020773
Approval Date: 29-OCT-98
Trade Name: SONORX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: BRACCO DIAGNOSTICS INC
Active Ingredient(s): SIMETHICONE-CELLULOSE
OTC/RX Status: RX
Indication(s): An orally administered gas shadowing reduction agent that is indicated to enhance the delineation of upper abdominal anatomy in conjuction with ultrasound imaging

Original Application #: 020932
Approval Date: 26-OCT-98
Trade Name: ROXICODONE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, SUSTAINED RELEASE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s):For the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days

Original Application #: 020844
Approval Date: 26-OCT-98
Trade Name: TOPAMAX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): TOPIRAMATE
OTC/RX Status: RX
Indication(s):For use as adjunctive therapy for the treatment of adults with partial onset seizures

Original Application #: 050759
Approval Date: 01-OCT-98
Trade Name: CELL CEPT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Indication(s): For the prophylaxis of organ rejection in patients receiving allogeneic renal transplants and in patients receiving allogeneic cardiac transplants

Efficacy Supplemental New Drug Applications

Application #:017970 Efficacy Supplement#: 040
Type: SE1 to Original New Drug Application
Approval Date: 29-OCT-98
Trade Name: NOLVADEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Efficacy Claim:For reducing the incidence of breast cancer in women at high risk for breast cancer

Application #: 020738 Efficacy Supplement#: 001
Type: SE2 to Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: TEVETEN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): EPROSARTAN MESYLATE
OTC/RX Status: RX
Efficacy Claim: For a new once daily dosing regimen

Application #:020357Efficacy Supplement#:010
Type: SE1 to Original New Drug Application
Approval Date: 22-OCT-98
Trade Name: GLUCOPHAGE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the new combination use of metformin and insulin in type 2 diabetes

Approvable Original New Drug Applications

Original Application #: 020936
Approvable Date: 09-OCT-98
Trade Name: PAXIL CR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Antibiotic Application# 064195
Approval Date: 31-OCT-98
Trade Name: SANGCYA
Dosage Form: SOLUTION
Applicant: SANGSTAT MEDICAL CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Original Abbreviated Application # 089886
Approval Date: 30-OCT-98
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: HERCON LABORATORIES CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 089885
Approval Date: 30-OCT-98
Trade Name: NITROGLYCERIN
Dosage Form: FILM, EXTENDED RELEASE
Applicant: HERCON LABORATORIES CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 089884
Approval Date: 30-OCT-98
Trade Name: NITROGLYCERIN
Dosage Form: FILM, EXTENDED RELEASE
Applicant: HERCON LABORATORIES CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 075155
Approval Date: 30-OCT-98
Trade Name: ISOSORBIDE MONITONITRATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KREMERS URBAN CO
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075037
Approval Date: 30-OCT-98
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 075285
Approval Date: 29-OCT-98
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: PERRIGO CO
Active Ingredient(s): CIMETIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075295
Approval Date: 28-OCT-98
Trade Name: MORPHINE SULFATE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 074737
Approval Date: 28-OCT-98
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 040261
Approval Date: 28-OCT-98
Trade Name: BUTALBITAL,ACETAMINOPHEN AND CAFFEINE
Dosage Form: CAPSULE
Applicant: WEST WARD INC
Active Ingredient(s): BUTALBITAL; ACETAMINOPHEN; CAFFEINE
OTC/RX Status: RX

Original Abbreviated Application # 075150
Approval Date: 05-OCT-98
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 075143
Approval Date: 16-OCT-98
Trade Name: HYDROXYUREA
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX

Original Abbreviated Application # 075136
Approval Date: 20-OCT-98
Trade Name: VERAPAMIL HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075149
Tentative Approval Date: 29-OCT-98
Trade Name: TICLOPIDINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075273
Tentative Approval Date: 28-OCT-98
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application #: 075062
Tentative Approval Date: 28-OCT-98
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074687
Tentative Approval Date: 28-OCT-98
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074984
Tentative Approval Date: 23-OCT-98
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075312
Tentative Approval Date: 15-OCT-98
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075311
Tentative Approval Date: 15-OCT-98
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074971
Tentative Approval Date: 14-OCT-98
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX

Original Abbreviated Application #: 074684
Tentative Approval Date: 09-OCT-98
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074684
Tentative Approval Date: 05-OCT-98
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: CHELSEA LABS
Active Ingredient(s): RANITIDINE HCL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020659 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 30-OCT-98
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 050317 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: LINCOCIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LINCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050316 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: LINCOCIN
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LINCOMYCIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 20668 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: LEXXEL
Dosage Form: TABLET
Applicant: ASTRA PHARMACEUTICALS
Active Ingredient(s): ENALAPRIL MALEATE/FELODIPINE ER
OTC/RX Status: RX

Application #: 020488 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: MAGNESIUM SULFATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): MAGNESIUM SULFATE
OTC/RX Status: RX

Application #: 020309 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: MAGNESIUM SULFATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): MAGNESIUM SULFATE
OTC/RX Status: RX

Application #: 019316 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: MAGNESIUM SULFATE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): MAGNESIUM SULFATE
OTC/RX Status: RX

Application #: 019778 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 28-OCT-98
Trade Name: PRINZIDE
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 20890 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 26-OCT-98
Trade Name: LOTRIMIN
Dosage Form: SOLUTION
Applicant: SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: RX

Application #: 020035 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 23-OCT-98
Trade Name: ERGAMISOL
Dosage Form: TABLET
Applicant: JANSSEN PHARMACEUTICA INC
Active Ingredient(s): LEVAMISOLE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020401 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 16-OCT-98
Trade Name: TIAZAC
Dosage Form: CAPSULE
Applicant: BIOVAIL LABS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016793 Labeling Supplement #: 059
To Original New Drug Application
Approval Date: 15-OCT-98
Trade Name: CYTOSAR-U
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): CYTARABINE
OTC/RX Status: RX

Application #: 20551 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 15-OCT-98
Trade Name: NIMBEX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME RESEARCH AND DEVELOPMENT
Active Ingredient(s): CISTRACURIUM BESYLATE
OTC/RX Status: RX

Application #: 020386 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 13-OCT-98
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX

Application #: 019221 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 13-OCT-98
Trade Name: VASERETIC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018061 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 13-OCT-98
Trade Name: TIMOLIDE
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): TIMOLOL MALEATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018045 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 09-OCT-98
Trade Name: EMCYT
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN
Active Ingredient(s): ESTRAMUSTINE PHOSPHATE SODIUM
OTC/RX Status: RX

Application #: 020121 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 01-OCT-98
Trade Name: FLONASE
Dosage Form: SPRAY
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX