Drug Approvals for January 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021208
Approval Date: 12-JAN-01
Trade Name: REMERON SOLTAB
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: ORGANON INC
Active Ingredient(s): MIRTAZAPINE
OTC/RX Status: RX
Indication(s): For the treatment of depression

Original Application #: 021252
Approval Date: 05-JAN-01
Trade Name: CANASA
Chemical Type: 5
Therapeutic Potential: P
Dosage Form: SUPPOSITORY
Applicant: AXCAN SCANDIPHARM INC
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX
Indication(s): Treatment of active ulcerative proctitis

Efficacy Supplemental New Drug Applications

Application #: 020560 Efficacy Supplement #: 025
Type: SE2 to Original New Drug Application
Approval Date: 31-JAN-01
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Efficacy Claim: For the treatment to increase bone mass in men with osteoporosis

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075887
Approval Date: 05-JAN-01
Trade Name: FLUVOXAMINE MALEATE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065057
Approval Date: 05-JAN-01
Trade Name: CEFACLOR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

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

Original Abbreviated Application #: 075790
Tentative Approval Date: 01-JAN-01
Trade Name: LORATADINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020560 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 31-JAN-01
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX

Application #: 019297 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 31-JAN-01
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 016979 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 31-JAN-01
Trade Name: MEGACE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX

Application #: 021251 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 30-JAN-01
Trade Name: KALETRA
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR; RITONAVIR
OTC/RX Status: RX

Application #: 021226 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 30-JAN-01
Trade Name: KALETRA
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR; RITONAVIR
OTC/RX Status: RX

Application #: 020180 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 30-JAN-01
Trade Name: PROSCAR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 012142 Labeling Supplement#: 103
To Original New Drug Application
Approval Date: 30-JAN-01
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#: 086
To Original New Drug Application
Approval Date: 30-JAN-01
Trade Name: CYTOXAN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CYCLOPHOSPHAMIDE
OTC/RX Status: RX

Application #: 020985 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 29-JAN-01
Trade Name: CARAC
Dosage Form: EMULSION, CREAM
Applicant: DERMIK LABORATORIES INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 23-JAN-01
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020180 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 17-JAN-01
Trade Name: PROSCAR
Dosage Form: TABLET
Applicant: MERCK RESEACH LABORATORIES
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 019653 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 16-JAN-01
Trade Name: ORTHO CYCLEN-28
Dosage Form: TABLET
Applicant: R.W. JOHNSON PHARMACEUTICAL AND RESEARCH INSTITUTE
Active Ingredient(s): NORGESTIMATE/ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019697 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 16-JAN-01
Trade Name: ORTHO TRI-CYCLEN
Dosage Form: TABLET
Applicant: R.W. JOHNSON PHARMACEUTICAL AND RESEARCH INSTITUTE
Active Ingredient(s): NORGESTIMATE/ETHINY ESTRADIOL
OTC/RX Status: RX

Application #:019821 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 11-JAN-01
Trade Name: SORIATANE
Dosage Form: CAPSULE
Applicant: HOFFMAN LA ROCHE INC
Active Ingredient(s): ACTRETIN
OTC/RX Status: RX

Application #: 021025 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 05-JAN-01
Trade Name: EXELON
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): RIVASTIGMINE TARTRATE
OTC/RX Status: RX

Application #: 020823 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 05-JAN-01
Trade Name: EXELON
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): RIVASTIGMINE TARTRATE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 05-JAN-01
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 05-JAN-01
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 050742 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 04-JAN-01
Trade Name: STROMECTOL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): IVERMECTIN
OTC/RX Status: RX

Application #: 050742 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 04-JAN-01
Trade Name: STROMECTOL
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): IVERMECTIN
OTC/RX Status: RX