Drug Approvals for December 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021165
Approval Date: 21-DEC-01
Trade Name: CLARINEX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): DESLORATADINE
OTC/RX Status: RX
Indication(s): For the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older

Original Application #: 021345
Approval Date: 07-DEC-01
Trade Name: ARIXTRA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: FONDA BV
Active Ingredient(s): FONDAPARINUX SODIUM
OTC/RX Status: RX
Indication(s): For the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism

Efficacy Supplemental New Drug Applications

Application #: 020903 Efficacy Supplement #: 013
Type: SE8 to Original New Drug Application
Approval Date: 28-DEC-01
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING CORPORATION
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX
Efficacy Claim: For use in combination with Intron A Injection for the treatment of chronic hepatits C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy

Application #: 020986 Efficacy Supplement#: 003
Type: SE3 to Original New Drug Application
Approval Date: 21-DEC-01
Trade Name: NOVOLOG
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN ASPART RECOMBINANT
OTC/RX Status: RX
Efficacy Claim: For the treatment of adult patients with diabetes mellitus, for the control of hyperglycemia

Application #: 021262 Efficacy Supplement#: 006
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-01
Trade Name: ALPHAGAN P
Dosage Form: SOLUTION, DROPS
Applicant: ALLERGAN INC
Active Ingredient(s): BRIMONIDINE TARTRATE
OTC/RX Status: RX
Efficacy Claim: For the prevention of post-operative IOP elevations in patients undergoing argon laser trabeculoplasty (ALT)

Application #: 020613 Efficacy Supplement#: 018
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-01
Trade Name: ALPHAGAN
Dosage Form: SOLUTION, DROPS
Applicant: ALLERGAN INC
Active Ingredient(s): BRIMONIDINE TARTRATE
OTC/RX Status: RX
Efficacy Claim:For the prevention of post-operative IOP elevations in patients undergoing argon laser trabeculoplasty (ALT)

Application #: 020490 Efficacy Supplement#: 007
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-01
Trade Name: ALPHAGAN
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): BRIMONIDINE TARTRATE
OTC/RX Status: RX
Efficacy Claim:For the prevention of post-operative IOP elevations in patients undergoing argon laser trabeculoplasty (ALT)

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 076092
Approval Date: 28-DEC-01
Trade Name: KETAMINE HCL
Dosage Form: INJECTABLE
Applicant: BIONICHE PHARMA
Active Ingredient(s): KETAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075674
Approval Date: 21-DEC-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075450
Approval Date: 21-DEC-01
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 076090
Approval Date: 20-DEC-01
Trade Name: PERMETHRIN
Dosage Form: LOTION
Applicant: CLAY-PARK LABS, INC
Active Ingredient(s): PERMETHRIN
OTC/RX Status: OTC

Original Abbreviated Application # 075927
Approval Date: 18-DEC-01
Trade Name: NAPROXEN
Dosage Form: TABLET
Applicant: INTERPHARM INC
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 065054
Approval Date: 18-DEC-01
Trade Name: CYCLOSPORINE
Dosage Form: SOLUTION
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Original Abbreviated Application # 075935
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075828
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075729
Approval Date: 17-DEC-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075636
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075551
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075451
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075300
Approval Date: 17-DEC-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 076152
Approval Date: 13-DEC-01
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET,EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075639
Approval Date: 12-DEC-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL COMPANY, INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 075661
Approval Date: 12-DEC-01
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: BASF CORP
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Original Abbreviated Application # 075427
Approval Date: 12-DEC-01
Trade Name: CROMOLYN SODIUM
Dosage Form: SPRAY, METERED
Applicant: L PERRIGO CO
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: OTC

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

Original Abbreviated Application #: 075510
Tentative Approval Date: 28-DEC-01
Trade Name: MILRINONE LACTATE IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE GENERICS
Active Ingredient(s): MILRINONE LACTATE
OTC/RX Status: RX

Original Abbreviated Application #: 076136
Tentative Approval Date: 26-DEC-01
Trade Name: CIPROFLOXACIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075743
Tentative Approval Date: 21-DEC-01
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL, INC.
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application #: 076058
Tentative Approval Date: 21-DEC-01
Trade Name: MIDAZOLAM HCL
Dosage Form: SYRUP
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 076134
Tentative Approval Date: 20-DEC-01
Trade Name: LORATADINE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Original Abbreviated Application #: 075752
Tentative Approval Date: 19-DEC-01
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant:ZENITH GOLDLINE PHARMACEUTICALS INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application #: 076093
Tentative Approval Date: 05-DEC-01
Trade Name: OFLOXACIN
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020441 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 31-DEC-01
Trade Name: PULMICORT TURBUHALER
Dosage Form: POWDER, FOR INHALATION
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX

Application #: 018662 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 31-DEC-01
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 018662 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 31-DEC-01
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 020457 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 21-DEC-01
Trade Name: ETOPOPHOS PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ETOPOSIDE PHOSPHATE
OTC/RX Status: RX

Application #: 020755 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 20-DEC-01
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX

Application #: 009698 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 13-DEC-01
Trade Name: MILTOWN
Dosage Form: TABLET
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): MEPROBAMATE
OTC/RX Status: RX

Application #: 018140 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 12-DEC-01
Trade Name: ATIVAN
Dosage Form:INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX

Application #: 012429 Labeling Supplement #: 017
To Original New Drug Application
Approval Date: 12-DEC-01
Trade Name: TABLOID
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): THIOGUANINE
OTC/RX Status: RX

Application #: 020231 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 10-DEC-01
Trade Name: COLGATE TOTAL
Dosage Form: PASTE
Applicant: COLGATE PALMOLIVE
Active Ingredient(s): TRICLOSAN; SODIUM FLUORIDE
OTC/RX Status: OTC

Application #: 019991 Labeling Supplement #: 031
To Original New Drug Application
Approval Date: 10-DEC-01
Trade Name: NOVOLIN 70/30
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
OTC/RX Status: OTC

Application #: 019959 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 10-DEC-01
Trade Name: NOVOLIN N
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
OTC/RX Status: OTC

Application #: 019938 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 10-DEC-01
Trade Name: NOVOLIN R
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICALS INC
Active Ingredient(s): INSULIN RECOMBINANT HUMAN
OTC/RX Status: OTC

Application #: 019957 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 09-DEC-01
Trade Name: CUTIVATE
Dosage Form: OINTMENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 019957 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 09-DEC-01
Trade Name: CUTIVATE
Dosage Form: OINTMENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 020788 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 08-DEC-01
Trade Name: PROPECIA
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 020723 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 08-DEC-01
Trade Name: ALDARA
Dosage Form: EMULSION, CREAM
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): IMIQUIMOD
OTC/RX Status: RX

Application #: 019463 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 07-DEC-01
Trade Name: TIMOPTIC IN OCUDOSE
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 018565 Labeling Supplement #: 009
To Original New Drug Application
Approval Date: 07-DEC-01
Trade Name: DURAMORPH PF
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX

Application #: 005378 Labeling Supplement #: 020
To Original New Drug Application
Approval Date: 06-DEC-01
Trade Name: DESOXYN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): METHAMPHETAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 04-DEC-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 #: 020330 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 03-DEC-01
Trade Name: TIMOPTIC-XE
Dosage Form: SOLUTION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020038 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 03-DEC-01
Trade Name: FLUDARA
Dosage Form: INJECTABLE
Applicant: BERLEX LABORATORIES INC SUB SCHERING AG
Active Ingredient(s): FLUDARABINE PHOSPHATE
OTC/RX Status: RX