Drug Approvals for May 1999

Definitions and Notes

May 1999

Original New Drug Applications

Original Application #: 021052
Approval Date: 20-MAY-99
Trade Name: VIOXX
Chemical Type:
Therapeutic Potential: P
Dosage Form: SUSPENSION
Applicant: MERCK AND CO INC
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX
Indication(s): For relief of the signs and symptoms of osteoarthritis, the management of acute pain, and the treatment of primary dysmenorrhea.

Original Application #: 021042
Approval Date: 20-MAY-99
Trade Name: VIOXX
Chemical Type:
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: MERCK AND CO INC PHARMACEUTICAL RESEARCH AND DEVELOPMENT LABORATORIES
Active Ingredient(s): ROFECOXIB
OTC/RX Status: RX
Indication(s): For relief of the signs and symptoms of osteoarthritis, the management of actue pain, and the treatment of primary dysmenorrhea.

Efficacy Supplemental New Drug Applications

Application #: 020584 Efficacy Supplement#: 003
Type: SE2 to Original New Drug Application
Approval Date: 27-MAY-99
Trade Name: LODINE XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Efficacy Claim: For the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis

Application #: 020680 Efficacy Supplement#: 011
Type: SE7 to Original New Drug Application
Approval Date: 26-MAY-99
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX
Efficacy Claim: For the use of Norvir, in combination with other antiretroviral agents, for the treatment of HIV-infection

Application #: 020659 Efficacy Supplement#: 013
Type: SE7 to Original New Drug Application
Approval Date: 26-MAY-99
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX
Efficacy Claim: For the use of Norvir, in combination with other antiretroviral agents, for the treatment of HIV-infection

Application #: 020031 Efficacy Supplement #: 023
Type: SE1 to Original New Drug Application
Approval Date: 11-MAY-99
Trade Name: PAXIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of social anxiety disorder

Application #: 010515 Efficacy Supplement#: 022
Type: SE1 to Original New Drug Application
Approval Date: 04-MAY-99
Trade Name: ISUPREL
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ISOPROTERENOL HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For pediatric use

Approvable Original New Drug Applications

Original Application #: 020950
Approvable Date: 28-MAY-99
Trade Name: DUOVENT
Dosage Form: SOLUTION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Application #: 020911
Approvable Date: 12-MAY-99
Trade Name: QVAR
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
OTC/RX Status: RX

Original Application #: 020823
Approvable Date: 12-MAY-99
Trade Name: EXELON
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): RIVASTIGMINE TARTRATE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075303
Approval Date: 28-MAY-99
Trade Name: LABETALOL HCL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): LABETALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075279
Approval Date: 28-MAY-99
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: GEL
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 075241
Approval Date: 28-MAY-99
Trade Name: FUROSEMIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): FUROSEMIDE
OTC/RX Status: RX

Original Abbreviated Application # 040331
Approval Date: 28-MAY-99
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040287
Approval Date: 28-MAY-99
Trade Name: PREDNISOLONE
Dosage Form: SYRUP
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): PREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Application # 075417
Approval Date: 27-MAY-99
Trade Name: CLOZAPINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Original Abbreviated Application # 075430
Approval Date: 26-MAY-99
Trade Name: CLOBETASOL PROPIONATE (EMOLLIENT)
Dosage Form: CREAM
Applicant: ALTANA INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 075337
Approval Date: 26-MAY-99
Trade Name: NAPROXEN
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX

Original Abbreviated Application # 075274
Approval Date: 26-MAY-99
Trade Name: NALTREXONE HCL
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): NALTREXONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075072
Approval Date: 25-MAY-99
Trade Name: VERAPAMIL HCL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074874
Approval Date: 25-MAY-99
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX

Original Abbreviated Application # 040216
Approval Date: 25-MAY-99
Trade Name: SULFACETAMIDE SODIUM
Dosage Form: SOLUTION
Applicant: AKORN INC
Active Ingredient(s): SULFACETAMIDE SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040215
Approval Date: 25-MAY-99
Trade Name: SULFACETAMIDE SODIUM
Dosage Form: SOLUTION
Applicant: AKORN INC
Active Ingredient(s): SULFACETAMIDE SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065000
Approval Date: 25-MAY-99
Trade Name: DAUNORUBICIN HYDROCHLORIDE
Dosage Form: INJECTABLE
Applicant: BIGMAR INC
Active Ingredient(s): DAUNORUBICIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075331
Approval Date: 14-MAY-99
Trade Name: DIFLORASONE DIACETATE
Dosage Form: OINTMENT
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): DIFLORASONE DIACETATE
OTC/RX Status: RX

Original Abbreviated Application # 040323
Approval Date: 13-MAY-99
Trade Name: PREDNISOLONE
Dosage Form: SYRUP
Applicant: UDL LABORATORIES INC
Active Ingredient(s): PREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Application # 040299
Approval Date: 13-MAY-99
Trade Name: DEXTROAMPHETAMINE SULFATE
Dosage Form: TABLET
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075393
Approval Date: 11-MAY-99
Trade Name: HALOPERIDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): HALOPERIDOL DECANOATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075451
Tentative Approval Date: 28-MAY-99
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application #: 075178
Tentative Approval Date: 28-MAY-99
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075128
Tentative Approval Date: 28-MAY-99
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application #: 074812
Tentative Approval Date: 11-MAY-99
Trade Name:POTASSIUM CHLORIDE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ESI LEDERLE INC
Active Ingredient(s): POTASSIUM CHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 017703 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 28-MAY-99
Trade Name: CYLERT
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Application #: 016832 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 28-MAY-99
Trade Name: CYLERT
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Application #: 012142 Labeling Supplement#: 102
To Original New Drug Application
Approval Date: 28-MAY-99
Trade Name: CYTOXAN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CYCLOPHOSPHAMIDE
OTC/RX Status: RX

Application #: 012141 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 28-MAY-99
Trade Name: CYTOXAN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CYCLOPHOSPHAMIDE
OTC/RX Status: RX

Application #: 050688 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 27-MAY-99
Trade Name: BANAN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 050687 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 27-MAY-99
Trade Name: BANAN
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): CEFPODOXIME PROXETIL
OTC/RX Status: RX

Application #: 020738 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 27-MAY-99
Trade Name: TEVETEN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): EPROSARTAN MESYLATE
OTC/RX Status: RX

Application #:020779Labeling Supplement#:020
To Original New Drug Application
Approval Date: 25-MAY-99
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020778 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 25-MAY-99
Trade Name: VIRACEPT
Dosage Form: POWDER, FOR ORAL SOLUTION
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020551 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-MAY-99
Trade Name: NIMBEX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CISATRACURIUM BESYLATE
OTC/RX Status: RX

Application #: 020551 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 21-MAY-99
Trade Name: NIMBEX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CISATRACURIUM BESYLATE
OTC/RX Status: RX

Application #: 020375 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 20-MAY-99
Trade Name: CLIMARA
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX

Application #: 018603 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 19-MAY-99
Trade Name: ZOVIRAX
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Application #: 018977 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 14-MAY-99
Trade Name: TRI-NORINYL 21-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL;
OTC/RX Status: RX

Application #: 018977 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 14-MAY-99
Trade Name: TRI-NORINYL 28-DAY
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL;
OTC/RX Status: RX

Application #: 017624 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 14-MAY-99
Trade Name: FORANE
Dosage Form: LIQUID
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): ISOFLURANE
OTC/RX Status: RX

Application #: 020491 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 13-MAY-99
Trade Name: CORVERT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN COMPANY
Active Ingredient(s): IBUTILIDE FUMARATE
OTC/RX Status: RX

Application #: 019856 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 10-MAY-99
Trade Name: SINEMET CR
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 019856 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 10-MAY-99
Trade Name: SINEMET CR
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 019856 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 10-MAY-99
Trade Name: SINEMET CR
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 019856 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 10-MAY-99
Trade Name: SINEMET CR
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 019856 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 10-MAY-99
Trade Name: SINEMET CR
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX

Application #: 020130 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 07-MAY-99
Trade Name: ESTROSTEP 21
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): NORETHINDRONE ACETATE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020013 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 06-MAY-99
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020013 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 06-MAY-99
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020013 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 06-MAY-99
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050577 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 05-MAY-99
Trade Name: ZANOSAR
Dosage Form: POWDER
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): STREPTOZOCIN
OTC/RX Status: RX

Application #: 018057 Labeling Supplement #: 072
To Original New Drug Application
Approval Date: 05-MAY-99
Trade Name: PLATINOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS CO
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX