Drug Approvals for June 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021288
Approval Date: 29-JUN-01
Trade Name: TRELSTAR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA
Active Ingredient(s): TRIPTORELIN PAMOATE
OTC/RX Status: RX
Indication(s): For the palliative treatment of advanced prostate cancer

Original Application #: 021238
Approval Date: 27-JUN-01
Trade Name: KYTRIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dost cisplatin and nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation

Original Application #: 021105
Approval Date: 26-JUN-01
Trade Name: ZOTRIM
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): SULFAMETHOXAZOLE; TRIMETHOPRIM
OTC/RX Status: RX
Indication(s): For the treatment of urinary tract infections and for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection

Original Application #: 050755
Approval Date: 22-JUN-01
Trade Name: AUGMENTIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUM
OTC/RX Status: RX
Indication(s): For the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. Pneumoniae (penicillin MICs 2mg/ml), H. Influenzae (including B-lactamase-producing strains), M. Catarrhalis (including B-lactamase-producing strains)

Original Application #: 021224
Approval Date: 22-JUN-01
Trade Name: REMINYL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN
Active Ingredient(s): GALANTAMINE HYDROBROMIDE
OTC/RX Status: RX
Indication(s): For the treatment of mild to moderate dementia of the Alzheimer's type

Original Application #: 021074
Approval Date: 07-JUN-01
Trade Name: AVAGARD
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: 3M HEALTH CARE INC
Active Ingredient(s): ALCOHOL, DEHYDRATED; CHLORHEXIDINE GLUCONATE
OTC/RX Status: OTC
Indication(s): For the use as a surgical hand scrub and healthcare personnel hand wash

Efficacy Supplemental New Drug Applications

Application #:020430Efficacy Supplement#:003
Type: SE8 to Original New Drug Application
Approval Date: 26-JUN-01
Trade Name: ORGARAN
Dosage Form: INJECTABLE
Applicant: ORGANON INC
Active Ingredient(s): DANAPAROID SODIUM
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of post-operative deep venous thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients undergoing elective hip replacement surgery

Application #: 020987 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 12-JUN-01
Trade Name: PROTONIX
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Efficacy Claim: For the maintenance of healing of erosive esophagitis and control of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD)

Application #: 020718 Efficacy Supplement#: 010
Type: SE2 to Original New Drug Application
Approval Date: 08-JUN-01
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with acute coronary syndrome (UA/NQM), including patinets who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). For the treatment of patients undergoing PCI, including those undergoing intracoronary stenting.

Application #: 020702 Efficacy Supplement#: 025
Type: SE8 to Original New Drug Application
Approval Date: 08-JUN-01
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: PFIZER IRELAND PHARMACEUTICALS
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Efficacy Claim: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb); as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV); for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet; to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075877
Approval Date: 26-JUN-01
Trade Name: TERBUTALINE SULFATE
Dosage Form: TABLET
Applicant: IMPAX LABORATORIES INC
Active Ingredient(s): TERBUTALINE SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 075644
Approval Date: 26-JUN-01
Trade Name: BISOPROLOL FUMARATE
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): BISOPROLOL FUMARATE
OTC/RX Status: RX

Original Abbreviated Application # 075861
Approval Date: 22-JUN-01
Trade Name: LEVOCARNITINE
Dosage Form: INJECTABLE
Applicant: LUITPOLD PHARMACEUTICALS, INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Original Abbreviated Application # 040421
Approval Date: 21-JUN-01
Trade Name: CARISOPRODOL
Dosage Form: TABLET
Applicant:ABLE LABORATORIES, INC
Active Ingredient(s): CARISOPRODOL
OTC/RX Status: RX

Original Abbreviated Application # 075858
Approval Date: 18-JUN-01
Trade Name: HALOPERIDOL
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Original Abbreviated Application # 075812
Approval Date: 15-JUN-01
Trade Name: DACARBAZINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES
Active Ingredient(s): DACARBAZINE
OTC/RX Status: RX

Original Abbreviated Application # 075451
Approval Date: 15-JUN-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS, INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075551
Approval Date: 15-JUN-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS, INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075300
Approval Date: 15-JUN-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS, INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075636
Approval Date: 15-JUN-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: EON LABS MANUFACTURING, INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075935
Approval Date: 15-JUN-01
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: GENPHARM, INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Original Abbreviated Application # 075795
Approval Date: 13-JUN-01
Trade Name: GLIPIZIDE
Dosage Form: TABLET
Applicant: TORPHARM
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075598
Approval Date: 13-JUN-01
Trade Name: MINOXIDIL TOPICAL SOLUTION USP, 5% (FOR MEN)
Dosage Form: SOLUTION
Applicant: L. PERRIGO COMPANY
Active Ingredient(s): MONOXIDIL
OTC/RX Status: RX

Original Abbreviated Application # 075750
Approval Date: 8-JUN-01
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: SIDMAK LABORATORIES, INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 075502
Approval Date: 05-JUN-01
Trade Name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Dosage Form: EMULSION, CREAM
Applicant: ALTANA INC
Active Ingredient(s): CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Original Abbreviated Application # 040386
Approval Date: 05-JUN-01
Trade Name: TRIAMCINOLONE ACETONIDE
Dosage Form: OINTMENT
Applicant: THAMES PHARMACAL CO INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX

Original Abbreviated Application # 040374
Approval Date: 05-JUN-01
Trade Name: TRIAMCINOLONE ACETONIDE
Dosage Form: OINTMENT
Applicant: THAMES PHARMACAL CO INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075727
Tentative Approval Date: 08-JUN-01
Trade Name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 075356
Tentative Approval Date: 07-JUN-01
Trade Name: PAROXETINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TORPHARM
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 016851 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 28-JUN-01
Trade Name: FML
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): FLUOROMETHOLONE
OTC/RX Status: RX

Application #: 021015 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 27-JUN-01
Trade Name: ANDROGEL
Dosage Form: GEL
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX

Application #: 020822 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 27-JUN-01
Trade Name: CELEXA
Dosage Form: TABLET
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): CITALOPRAM HYDROBROMIDE
OTC/RX Status: RX

Application #: 020862 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: HECTOROL
Dosage Form: CAPSULE
Applicant: BONE CARE INTERNATIONAL INC
Active Ingredient(s): DOXERCALCIFEROL
OTC/RX Status: RX

Application #: 020766 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: XENICAL
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ORLISTAT
OTC/RX Status: RX

Application #: 020550 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020550 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020132 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 25-JUN-01
Trade Name: IMITREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN SUCCINATE
OTC/RX Status: RX

Application #: 019885 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 21-JUN-01
Trade Name: ACCUPRIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020698 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 20-JUN-01
Trade Name: MIRALAX
Dosage Form: POWDER, FOR SOLUTION
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): POLYETHYLENE GLYCOL 3350
OTC/RX Status: RX

Application #: 020690 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 20-JUN-01
Trade Name: ARICEPT
Dosage Form: TABLET
Applicant: EISAI INC
Active Ingredient(s): DONEPEZIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 010669 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 20-JUN-01
Trade Name: LEUKERAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CHLORAMBUCIL
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 19-JUN-01
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 19-JUN-01
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020301 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 19-JUN-01
Trade Name: ORTHO-CEPT
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016721 Labeling Supplement#: 074
To Original New Drug Application
Approval Date: 14-JUN-01
Trade Name: DALMANE
Dosage Form: CAPSULE
Applicant: ICN PHARMACEUTICALS INC
Active Ingredient(s): FLURAZEPAM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020604 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 13-JUN-01
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020622 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 12-JUN-01
Trade Name: COPAXONE
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): GLATIRAMER ACETATE
OTC/RX Status: RX

Application #: 017442 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 12-JUN-01
Trade Name: MINIPRESS
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): PRAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020718 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 08-JUN-01
Trade Name: INTEGRILIN
Dosage Form: INJECTABLE
Applicant: COR THERAPEUTICS INC
Active Ingredient(s): EPTIFIBATIDE
OTC/RX Status: RX

Application #: 020165 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 08-JUN-01
Trade Name: NICODERM CQ
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): NICOTINE
OTC/RX Status: RX

Application #: 018897 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 07-JUN-01
Trade Name: SODIUM CHLORIDE IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 020214 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 05-JUN-01
Trade Name: ZEMURON
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): ROCURONIUM BROMIDE
OTC/RX Status: RX

Application #: 016949 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 05-JUN-01
Trade Name: LIMBITROL
Dosage Form: TABLET
Applicant: ICN PHARMACEUTICALS INC
Active Ingredient(s): CHLORDIAZEPOXIDE; AMITRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050779 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 01-JUN-01
Trade Name: CEFAZOLIN AND DEXTROSE
Dosage Form: INJECTABLE
Applicant: B BRAUN MEDICAL INC
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX