Drug Approvals for July 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 050779
Approval Date: 27-JUL-00
Trade Name: CEFAZOLIN AND DEXTROSE
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: B BRAUN MEDICAL INC
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX
Indication(s): For the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, endocarditis, and perioperative prophylaxis

Original Application #: 020941
Approval Date: 25-JUL-00
Trade Name: ABREVA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: AVANIR PHARMACEUTICALS
Active Ingredient(s): DOCOSANOL
OTC/RX Status: OTC
Indication(s): For the treatment cold sore/fever blister

Original Application #: 020610
Approval Date: 18-JUL-00
Trade Name: COLAZAL
Chemical Type:
Therapeutic Potential:
Dosage Form: CAPSULE
Applicant: SALIX PHARMACEUTICALS INC
Active Ingredient(s): BALSALAZIDE DISODIUM
OTC/RX Status: RX
Indication(s): For the treatment of mildly to moderately active ulcerative colitis

Original Application #: 020832
Approval Date: 14-JUL-00
Trade Name: CHLORAPREP
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: MEDI FLEX HOSP PRODUCTS INC
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: OTC
Indication(s): For use as a patient preoperative skin preparation

Original Application #: 021078
Approval Date: 14-JUL-00
Trade Name: MALARONE
Chemical Type: 4
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ATOVAQUONE; PROGUANIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment and prevention of Plasmodium falciparum malaria

Original Application #: 020484
Approval Date: 14-JUL-00
Trade Name: INNOHEP
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): TINZAPARIN SODIUM
OTC/RX Status: RX
Indication(s): For the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium

Original Application #: 021179
Approval Date: 12-JUL-00
Trade Name: RENAGEL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
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 (ESRD)

Efficacy Supplemental New Drug Applications

Application #: 050759 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 28-JUL-00
Trade Name: CELLCEPT
Dosage Form: SUSPENSION
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants

Application #: 050758 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 28-JUL-00
Trade Name: CELLCEPT
Dosage Form: INJECTABLE
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): MYCOPHENOLATE MOFETIL HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants

Application #: 050723 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 28-JUL-00
Trade Name: CELLCEPT
Dosage Form: TABLET
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants

Application #: 050722 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 28-JUL-00
Trade Name: CELLCEPT
Dosage Form: CAPSULE
Applicant: ROCHE GLOBAL DEVELOPMENT
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of organ rejection in patients receiving allogeneic hepatic transplants

Application #: 020156 Efficacy Supplement #: 025
Type: SE8 to Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSITUTION
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: Provide for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the VIDEX label and VIDEX patient package insert, and the recommendation that twice-daily administration of VIDEX is the preferred dosing frequency

Application #: 020155 Efficacy Supplement #: 024
Type: SE8 to Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSITUTION
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: Provide for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the VIDEX label and VIDEX patient package insert, and the recommendation that twice-daily administration of VIDEX is the preferred dosing frequency

Application #: 020154 Efficacy Supplement #: 033
Type: SE8 to Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: TABLET
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: Provide for the inclusion of a detailed description of the 48-week final results of study AI454-148 in the VIDEX label and VIDEX patient package insert, and the recommendation that twice-daily administration of VIDEX is the preferred dosing frequency

Application #: 020740 Efficacy Supplement #: 013
Type: SE1 to Original New Drug Application
Approval Date: 21-JUL-00
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familian and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and Iib)

Application #: 020740 Efficacy Supplement #: 008
Type: SE2 to Original New Drug Application
Approval Date: 21-JUL-00
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the reduction of elevated LDL-cholesterol in a new, higher strength tablet, 0.8 mg, and for extension of the dosage range to 0.8 mg daily

Application #:018936Efficacy Supplement#:058
Type: SE1 to Original New Drug Application
Approval Date: 06-JUL-00
Trade Name: SARAFEM
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of PMDD (premenstrual dysphoric disorder)

Approvable Original New Drug Applications

Original Application #: 021190
Approvable Date: 24-JUL-00
Trade Name: BUSPAR
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075667
Approval Date: 28-JUL-00
Trade Name: TERAZOSIN HCL
Dosage Form: CAPSULE
Applicant: INVAMED INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075419
Approval Date: 28-JUL-00
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: TORPHARM INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074881
Approval Date: 28-JUL-00
Trade Name: IOPAMIDOL-200
Dosage Form: INJECTABLE
Applicant: COOK IMAGING CORP
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074881
Approval Date: 28-JUL-00
Trade Name: IOPAMIDOL-250
Dosage Form: INJECTABLE
Applicant: COOK IMAGING CORP
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074881
Approval Date: 28-JUL-00
Trade Name: IOPAMIDOL-300
Dosage Form: INJECTABLE
Applicant: COOK IMAGING CORP
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 074881
Approval Date: 28-JUL-00
Trade Name: IOPAMIDOL-370
Dosage Form: INJECTABLE
Applicant: COOK IMAGING CORP
Active Ingredient(s): IOPAMIDOL
OTC/RX Status: RX

Original Abbreviated Application # 075678
Approval Date: 26-JUL-00
Trade Name: PEMOLINE
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 040400
Approval Date: 26-JUL-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040309
Approval Date: 26-JUL-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040308
Approval Date: 26-JUL-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 040307
Approval Date: 26-JUL-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): HYDROCODONE BITARTRATE; ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 040351
Approval Date: 25-JUL-00
Trade Name: HYDROCORTISONE
Dosage Form: LOTION
Applicant: ALTANA INC
Active Ingredient(s): HYDROCORTISONE
OTC/RX Status: RX

Original Abbreviated Application # 075238
Approval Date: 13-JUL-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065012
Approval Date: 03-JUL-00
Trade Name: CEFOXITIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065011
Approval Date: 03-JUL-00
Trade Name: CEFOXITIN
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX

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

Original Abbreviated Application #: 075718
Tentative Approval Date: 27-JUL-00
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: CHEMINOR DRUGS LTD
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075119
Tentative Approval Date: 27-JUL-00
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: AEGIS PHARMACEUTICALS LTD
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075580
Tentative Approval Date: 26-JUL-00
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application #: 075453
Tentative Approval Date: 26-JUL-00
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application #: 075388
Tentative Approval Date: 26-JUL-00
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: PHARMAX PRODUCTS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075598
Tentative Approval Date: 24-JUL-00
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: PERRIGO CO
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC

Original Abbreviated Application #: 075536
Tentative Approval Date: 24-JUL-00
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application #: 075289
Tentative Approval Date: 24-JUL-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED-RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 013025 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 26-JUL-00
Trade Name: THAM SOLUTION
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): TROMETHAMINE
OTC/RX Status: RX

Application #: 019764 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 26-JUL-00
Trade Name: SAIZEN
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES, INC
Active Ingredient(s): SOMATROPIN
OTC/RX Status: RX

Application #: 020156 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020155 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020154 Labeling Supplement #: 032
To Original New Drug Application
Approval Date: 24-JUL-00
Trade Name: VIDEX
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 021047 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 21-JUL-00
Trade Name: REPRONEX
Dosage Form: INJECTABLE
Applicant: FERRING PHARMACEUTICALS INC
Active Ingredient(s): MENOTROPINS
OTC/RX Status: RX

Application #: 020668 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 18-JUL-00
Trade Name: LEXXEL
Dosage Form: TABLET
Applicant: ASTRAZENECA LP
Active Ingredient(s): FELODIPINE; ENALAPRIL MALEATE
OTC/RX Status: RX

Application #: 020604 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-JUL-00
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 021065 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 14-JUL-00
Trade Name: FEMHRT
Dosage Form: TABLET
Applicant: PARKE DAVIS
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019787 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 12-JUL-00
Trade Name: NORVASC
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): AMLODIPINE BESYLATE
OTC/RX Status: RX

Application #: 019002 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 12-JUL-00
Trade Name: VASCOR
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): BEPRIDIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 021071 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-JUL-00
Trade Name: AVANDIA
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): ROSIGLITAZONE MALEATE
OTC/RX Status: RX

Application #: 020545 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 11-JUL-00
Trade Name: PROCANBID
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): PROCAINAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020280 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 11-JUL-00
Trade Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020811 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 07-JUL-00
Trade Name: ACULAR PRESERVATIVE FREE
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 020369 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 07-JUL-00
Trade Name: CILOXAN
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019865 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 07-JUL-00
Trade Name: BETAPACE
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020451 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 06-JUL-00
Trade Name: PHOTOFRIN
Dosage Form: INJECTABLE
Applicant: AXCAN SCANDIPHARM INC
Active Ingredient(s): PORFIMER SODIUM
OTC/RX Status: RX