Drug Approvals for September 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021279
Approval Date: 25-SEP-01
Trade Name: FORADIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER, FOR INHALATION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FORMOTEROL FUMARATE
OTC/RX Status: RX
Indication(s): For the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema

Original Application #: 021203
Approval Date: 04-SEP-01
Trade Name: TRICOR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): FENOFIBRATE
OTC/RX Status: RX
Indication(s): For adjunctive therapy to diet to reduce elevated LDL-C, Total_C, triglycerides and Apo-B and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed lipidemia (Fredrickson Types Iia and IIb), and as adjuctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia)

Efficacy Supplemental New Drug Applications

Application #: 020708 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 21-SEP-01
Trade Name: LUPRON DEPOT-3 MONTH
Dosage Form: INJECTABLE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Efficacy Claim: For the use of Lupron Depot 3-Month 11.25 mg with norethindron acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms

Application #: 020011 Efficacy Supplement#: 021
Type: SE1 to Original New Drug Application
Approval Date: 21-SEP-01
Trade Name: LUPRON DEPOT
Dosage Form: INJECTABLE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Efficacy Claim: > For the use of Lupron Depot 3.75 mg monthly with norethindron acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms

Application #: 020896 Efficacy Supplement #: 010
Type: SE7 to Original New Drug Application
Approval Date: 07-SEP-01
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HLR TECHNOLOGY
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX
Efficacy Claim: Provides for the use of Xeloda in combination with Taxotere for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 076121
Approval Date: 27-SEP-01
Trade Name: LITHIUM CARBONATE
Dosage Form: CAPSULE
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): LITHIUM CARBONATE
OTC/RX Status: RX

Original Abbreviated Application # 075562
Approval Date: 27-SEP-01
Trade Name: IPRATROPIUM BROMIDE
Dosage Form: SOLUTION
Applicant: NEPHRON CORP
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075820
Approval Date: 18-SEP-01
Trade Name: FLUTAMIDE
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): FLUTAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075818
Approval Date: 18-SEP-01
Trade Name: FLUTAMIDE
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FLUTAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075788
Approval Date: 18-SEP-01
Trade Name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICALS USA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 075727
Approval Date: 18-SEP-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 # 075624
Approval Date: 18-SEP-01
Trade Name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 065047
Approval Date: 18-SEP-01
Trade Name: CEFAZOLIN SODIUM
Dosage Form: INJECTABLE
Applicant: HIKMA FARMACEUTICA LDA
Active Ingredient(s): CEFAZOLIN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075650
Approval Date: 14-SEP-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075209
Approval Date: 13-SEP-01
Trade Name: LORATADINE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): LORATADINE
OTC/RX Status: RX

Original Abbreviated Application # 075558
Approval Date: 11-SEP-01
Trade Name: VECURONIUM BROMIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): VECURONIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#065026
Approval Date: 11-SEP-01
Trade Name: TOBRAMYCIN
Dosage Form: SOLUTION
Applicant: ALTANA INC
Active Ingredient(s): TOBRAMYCIN
OTC/RX Status: RX

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

Original Abbreviated Application #: 075934
Tentative Approval Date: 28-SEP-01
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075662
Tentative Approval Date: 17-SEP-01
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 076101
Tentative Approval Date: 14-SEP-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application #: 076024
Tentative Approval Date: 12-SEP-01
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075807
Tentative Approval Date: 12-SEP-01
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 019152 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 28-SEP-01
Trade Name: ISOPTIN SR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050667 Labeling Supplement#: 022
Nizatidine Capsules USP, Genpharm Inc.To Original New Drug Application
Approval Date: 27-SEP-01
Trade Name: LORABID
Dosage Form: SUSPENSION
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX

Application #: 020758 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 26-SEP-01
Trade Name: AVALIDE
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): IRBESARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020757 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 26-SEP-01
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX

Application #: 012093 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 26-SEP-01
Trade Name: ISORDIL TITRADOSE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 021192 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: LESCOL XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX

Application #: 020261 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX

Application #: 020913 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020831 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: FORADIL
Dosage Form: POWDER, FOR INHALATION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FORMOTEROL FUMARATE
OTC/RX Status: RX

Application #: 018021 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 25-SEP-01
Trade Name: ASENDIN
Dosage Form: TABLET
Applicant:WYETH-AYERST LABORATORIES
Active Ingredient(s): AMOXAPINE
OTC/RX Status: RX

Application #: 021228 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 21-SEP-01
Trade Name: DETROL LA
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLTERODINE TARTRATE
OTC/RX Status: RX

Application #: 020668 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 18-SEP-01
Trade Name: LEXXEL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): FELODIPINE; ENALAPRIL MALEATE
OTC/RX Status: RX

Application #: 018201 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 18-SEP-01
Trade Name: MODURETIC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018200 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 18-SEP-01
Trade Name: MIDAMOR
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): AMILORIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012940 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 16-SEP-01
Trade Name: ISORDIL SUBLORAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): ISOSORBIDE DINITRATE
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 13-SEP-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORPORATION
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 13-SEP-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORPORATION
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 020367 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 13-SEP-01
Trade Name: CEREZYME
Dosage Form: INJECTABLE
Applicant: GENZYME CORPORATION
Active Ingredient(s): IMIGLUCERASE
OTC/RX Status: RX

Application #: 010379 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 13-SEP-01
Trade Name: CYTOMEL
Dosage Form: TABLET
Applicant: JONES PHARMA INC SUB KING PHARMACEUTICALS INC
Active Ingredient(s): LIOTHYRONINE SODIUM
OTC/RX Status: RX

Application #: 018803 Labeling Supplement #: 012
To Original New Drug Application
Approval Date: 12-SEP-01
Trade Name: SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 020156 Labeling Supplement #: 027
To Original New Drug Application
Approval Date: 10-SEP-01
Trade Name: VIDEX
Dosage Form: POWDER, FOR SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020155 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 10-SEP-01
Trade Name: VIDEX
Dosage Form: POWDER, FOR SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020154 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 10-SEP-01
Trade Name: VIDEX
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX

Application #: 020896 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 07-SEP-01
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HLR TECHNOLOGY
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX

Application #: 019012 Labeling Supplement #: 028
To Original New Drug Application
Approval Date: 07-SEP-01
Trade Name: MOTRIN IB
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 020604 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 06-SEP-01
Trade Name: SEROSTIM
Dosage Form: INJECTALE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020243 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 06-SEP-01
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

Application #: 021015 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 05-SEP-01
Trade Name: ANDROGEL
Dosage Form: GEL
Applicant: UNIMED PHARMACEUTICALS INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX

Application #: 020329 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 05-SEP-01
Trade Name: GLUCOTROL XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PFIZER INC
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX

Application #: 020785 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 04-SEP-01
Trade Name: THALOMID
Dosage Form: CAPSULE
Applicant: CELGENE CORP
Active Ingredient(s): THALIDOMIDE
OTC/RX Status: RX

Application #: 020785 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 04-SEP-01
Trade Name: THALOMID
Dosage Form: CAPSULE
Applicant: CELGENE CORP
Active Ingredient(s): THALIDOMIDE
OTC/RX Status: RX

Application #: 018654 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 04-SEP-01
Trade Name: VERSED
Dosage Form: INJECTABLE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX