Drug Approvals for October 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 020958
Approval Date: 16-OCT-00
Trade Name: PEPCID COMPLETE
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE
OTC/RX Status: OTC
Indication(s): For use in the relief of heartburn associated with acid indigestion and sour stomach

Original Application #: 021120
Approval Date: 13-OCT-00
Trade Name: NOVANTRONE
Chemical Type: 6
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses)

Original Application #: 021216
Approval Date: 12-OCT-00
Trade Name: NEURONTIN
Chemical Type: 6
Therapeutic Potential: P
Dosage Form: SOLUTION
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Indication(s): As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Original Application #: 021192
Approval Date: 06-OCT-00
Trade Name: LESCOL XL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX
Indication(s): For the use as an adjunct to diet to reduce elevated total cholesterol (total-C), LDL-C, TG, and Apo B levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate; to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels

Original Application #: 020874
Approval Date: 05-OCT-00
Trade Name: LUNELLE
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX
Indication(s): For the prevention of pregnancy

Efficacy Supplemental New Drug Applications

Application #: 020685 Efficacy Supplement #: 043
Type: SE8 to Original New Drug Application
Approval Date: 23-OCT-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant:MERCK RESEARCH LABORATORIES
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Efficacy Claim: In combination with antiretroviral agents is indicated for the treatment of HIV infection

Application #: 020261 Efficacy Supplement#: 024
Type: SE8 to Original New Drug Application
Approval Date: 23-OCT-00
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORPORATION
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For use as a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerosis vascular disease due to hypercholesterolemia

Application #: 050662 Efficacy Supplement#: 029
Type: SE1 to Original New Drug Application
Approval Date: 20-OCT-00
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: For the addition of Haemophilus influenzae to the previously approved indication of Community-Acquired Pneumonia for Biaxin Filmtab

Application #: 021024 Efficacy Supplement #: 005
Type: SE7 to Original New Drug Application
Approval Date: 20-OCT-00
Trade Name: PRIFTIN
Dosage Form: TABLET
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): RIFAPENTINE
OTC/RX Status: RX
Efficacy Claim: For the treatment of pulmonary tuberculosis in conjunction with at least one other antituberculosis drug to which the isolate is susceptible

Application #: 020882 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 12-OCT-00
Trade Name: NEURONTIN
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Efficacy Claim: As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Application #: 020235 Efficacy Supplement#: 015
Type: SE1 to Original New Drug Application
Approval Date: 12-OCT-00
Trade Name: NEURONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS PHARMACEUTICALS LTD
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX
Efficacy Claim:As an adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 years and above

Application #: 019901 Efficacy Supplement #: 028
Type: SE1 to Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: ALTACE
Dosage Form: CAPSULE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): RAMIPRIL
OTC/RX Status: RX
Efficacy Claim: For the reduction in risk of myocardial infarction, stroke, and death from cardiovascular causes

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075637
Approval Date: 31-OCT-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075564
Approval Date: 27-OCT-00
Trade Name: RANITIDINE HCL
Dosage Form: CAPSULE
Applicant: GENPHARM INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075641
Approval Date: 19-OCT-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075609
Approval Date: 18-OCT-00
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: KV PHARMACEUTICAL CO
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 075432
Approval Date: 18-OCT-00
Trade Name: DOXAZOSIN MESYLATE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 075613
Approval Date: 10-OCT-00
Trade Name: BUPROPION HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075468
Approval Date: 06-OCT-00
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX

Original Abbreviated Application # 075361
Approval Date: 05-OCT-00
Trade Name: ISOSORBIDE MONONITRATE
Dosage Form: TABLET
Applicant: WESTWARD PHARMACEUTICAL CORP
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Original Abbreviated Application # 040304
Approval Date: 02-OCT-00
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075616
Tentative Approval Date: 25-OCT-00
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075671
Tentative Approval Date: 23-OCT-00
Trade Name: MEGESTROL ACETATE
Dosage Form: SUSPENSION
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX

Original Abbreviated Application #: 075297
Tentative Approval Date: 10-OCT-00
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 009000 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 009000 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: CAFERGOT
Dosage Form: SUPPOSITORY
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ERGOTAMINE TARTRATE; CAFFEINE
OTC/RX Status: RX

Application #: 018458 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 31-OCT-00
Trade Name: TALACEN
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): PENTAZOCINE HYDROCHLORIDE; ACETAMINOPHEN
OTC/RX Status: RX

Application #: 021174 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 27-OCT-00
Trade Name: MYLOTARG
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): GEMTUZUMAB OZOGAMICIN
OTC/RX Status: RX

Application #: 020604 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 27-OCT-00
Trade Name: SEROSTIM
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020771 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 24-OCT-00
Trade Name: DETROL
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLTERODINE TARTRATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 23-OCT-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020685 Labeling Supplement #: 030
To Original New Drug Application
Approval Date: 23-OCT-00
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020830 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 17-OCT-00
Trade Name: SINGULAIR
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020829 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-OCT-00
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 018983 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 16-OCT-00
Trade Name: COLYTE
Dosage Form: SOLUTION
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 018983 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 16-OCT-00
Trade Name: COLYTE
Dosage Form: SOLUTION
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): SODIUM SULFATE; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
OTC/RX Status: RX

Application #: 021129 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 12-OCT-00
Trade Name: NEURONTIN
Dosage Form: SOLUTION
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): GABAPENTIN
OTC/RX Status: RX

Application #: 019668 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 10-OCT-00
Trade Name: CARDURA
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): DOXAZOSIN MESYLATE
OTC/RX Status: RX

Application #: 020261 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 06-OCT-00
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX

Application #: 019970 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 06-OCT-00
Trade Name: NITROGLYCERIN IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 050668 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 05-OCT-00
Trade Name: LORABID
Dosage Form: CAPSULE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX

Application #: 050667 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 05-OCT-00
Trade Name: LORABID
Dosage Form: SUSPENSION
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX

Application #: 009768 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 05-OCT-00
Trade Name: PLAQUENIL
Dosage Form: TABLET
Applicant: SANOFI SYNTHELABO INC
Active Ingredient(s): HYDROXYCHLOROQUINE SULFATE
OTC/RX Status: RX

Application #: 050716 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: NEORAL
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050715 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: NEORAL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050625 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: SANDIMMUNE
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050574 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: SANDIMMUNE
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050573 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 04-OCT-00
Trade Name: SANDIMMUNE
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050091 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 03-OCT-00
Trade Name: CHLOROPTIC
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): CHLORAMPHENICOL
OTC/RX Status: RX

Application #: 020713 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 03-OCT-00
Trade Name: MIRCETTE
Dosage Form: TABLET
Applicant: ORGANON INC SUB AKZO NOBEL INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020607 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 03-OCT-00
Trade Name: ARTHROTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL
OTC/RX Status: RX

Application #: 018831 Labeling Supplement #: 022
To Original New Drug Application
Approval Date: 03-OCT-00
Trade Name: TRACRIUM PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Application #: 018831 Labeling Supplement #: 021
To Original New Drug Application
Approval Date: 03-OCT-00
Trade Name: TRACRIUM PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Application #: 020516 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 02-OCT-00
Trade Name: CHILDREN'S MOTRIN
Dosage Form: SUSPENSION
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 019012 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 02-OCT-00
Trade Name: NUPRIN
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 008453 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 02-OCT-00
Trade Name: ANECTINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUCCINYLCHOLINE CHLORIDE
OTC/RX Status: RX