Drug Approvals for August 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 021110
Approval Date: 25-AUG-00
Trade Name: RAPAMUNE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: WYETH-AYERST RESEARCH
Active Ingredient(s): SIROLIMUS
OTC/RX Status: RX
Indication(s): For the prophylaxis of organ rejection in patients receiving renal transplants

Original Application #: 021199
Approval Date: 18-AUG-00
Trade Name: QUIXIN
Chemical Type: 2
Therapeutic Potential: P
Dosage Form: SOLUTION, DROPS
Applicant: SANTEN INC
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Indication(s): For the treatment of bacterial conjunctivitis

Original Application #: 021167
Approval Date: 16-AUG-00
Trade Name: VIVELLE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: PATCH, CONTROLLED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): For the prevention of postmenopausal osteoporosis.

Original Application #: 021197
Approval Date: 11-AUG-00
Trade Name: CETROTIDE
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ASTA MEDICA INC
Active Ingredient(s): CETRORELIX
OTC/RX Status: RX
Indication(s): For the prevention of premature LH surges in women undergoing controlled ovarian stimulation

Original Application #: 021128
Approval Date: 01-AUG-00
Trade Name: CHILDREN’S MOTRIN COLD
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: MCNEIL CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HCL
OTC/RX Status: OTC
Indication(s): For the temporary relief of nasal and sinus congestion, minor body aches and pains, fever, stuffy nose, headache, and sore throat

Original Application #: 021168
Approval Date: 04-AUG-00
Trade Name: DEPAKOTE ER
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DIVALPROEX SODIUM
OTC/RX Status: RX
Indication(s): For the prophylaxis of migraine headaches in adults

Original Application #: 021214
Approval Date: 03-AUG-00
Trade Name: RESCULA
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: SOLUTION, DROPS
Applicant: CIBA VISION CORP DIV NOVARTIS CO
Active Ingredient(s): UNOPROSTONE ISOPROPYL
OTC/RX Status: RX
Indication(s): For the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insuffiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication

Original Application #: 021121
Approval Date: 01-AUG-00
Trade Name: CONCERTA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of attention deficit disorder

Efficacy Supplemental New Drug Applications

Application #: 020780 Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: CIPRO
Dosage Form: POWDER
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For inhalational anthrax (post-exposure)

Application #: 019858 Efficacy Supplement #: 021
Type: SE1 to Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For inhalational anthrax (post-exposure)

Application #: 019857 Efficacy Supplement #: 027
Type: SE1 to Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For inhalational anthrax (post-exposure)

Application #: 019847 Efficacy Supplement #: 024
Type: SE1 to Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For inhalational anthrax (post-exposure)

Application #: 019537 Efficacy Supplement #: 038
Type: SE1 to Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For inhalational anthrax (post-exposure)

Application #: 020508 Efficacy Supplement#: 005
Type: SE8 to Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: LAC-HYDRIN
Dosage Form: CREAM
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): AMMONIUM LACTATE
OTC/RX Status: RX
Efficacy Claim: For the treatment of ichthyosis vulgaris and xerosis in pediatric patients as young as 2 years old

Application #: 018869 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 22-AUG-00
Trade Name: NIMOTOP
Dosage Form: CAPSULE
Applicant: BAYER CORP
Active Ingredient(s): NIMODIPINE
OTC/RX Status: RX
Efficacy Claim: For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V)

Application #: 020584 Efficacy Supplement#: 005
Type: SE5 to Original New Drug Application
Approval Date: 11-AUG-00
Trade Name: LODINE XL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Efficacy Claim: For juvenile rheumatoid arthritis

Application #: 020287 Efficacy Supplement #: 018
Type: SE2 to Original New Drug Application
Approval Date: 03-AUG-00
Trade Name: FRAGMIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DALTEPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction in patients, when concurrently administered with aspirin therapy

Application #: 020164 Efficacy Supplement #: 020
Type: SE8 to Original New Drug Application
Approval Date: 03-AUG-00
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS PRODUCTS, INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: Provides for changes to the CLINICAL TRIALS section, the “Unstable Angina and Non-Q-Wave Myocardial Infarction” subsection, regarding the one year follow-up period

Approvable Original New Drug Applications

Original Application #: 020929
Approvable Date: 08-AUG-00
Trade Name: PULMICORT
Dosage Form: INHALANT
Applicant: ASTRAZENECA LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075634
Approval Date: 22-AUG-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application # 075583
Approval Date: 22-AUG-00
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 075578
Approval Date: 22-AUG-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application # 075571
Approval Date: 22-AUG-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application # 075458
Approval Date: 22-AUG-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application # 075456
Approval Date: 22-AUG-00
Trade Name: ENALAPRILAT
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX

Original Abbreviated Application # 075475
Approval Date: 03-AUG-00
Trade Name: LEVOBUNOLOL HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075473
Approval Date: 03-AUG-00
Trade Name: LEVOBUNOLOL HCL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075572
Tentative Approval Date: 04-AUG-00
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: KV PHARMACEUTICAL CO
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075272
Tentative Approval Date: 02-AUG-00
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 011795 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: VISTARIL
Dosage Form: SUSPENSION
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE PAMOATE
OTC/RX Status: RX

Application #: 011459 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: VISTARIL
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE PAMOATE
OTC/RX Status: RX

Application #: 020415 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 30-AUG-00
Trade Name: REMERON
Dosage Form: TABLET
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): MIRTAZAPINE
OTC/RX Status: RX

Application #: 050587 Labeling Supplement#: 052
To Original New Drug Application
Approval Date: 28-AUG-00
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX

Application #: 020656 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 28-AUG-00
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020168 Labeling Supplement #: 016
To Original New Drug Application
Approval Date: 28-AUG-00
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENENTECH INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 019834 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 28-AUG-00
Trade Name: PLENDIL
Dosage Form: TABLET
Applicant: ASTRAZENECA LP
Active Ingredient(s): FELODIPINE
OTC/RX Status: RX

Application #: 050585 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: ROCEPHIN
Dosage Form: INJECTABLE
Applicant: HOFFMAN-LAROCHE INC
Active Ingredient(s): CEFTRIAXONE SODIUM
OTC/RX Status: RX

Application #: 021083 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: RAPAMUNE
Dosage Form: SOLUTION
Applicant: WYETH-AYERST RESEARCH
Active Ingredient(s): SIROLIMUS
OTC/RX Status: RX

Application #: 020763 Labeling Supplement #: 002
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: AMERGE
Dosage Form: TABLET
Applicant: GLAXO WELLCOME, INC
Active Ingredient(s): NARATRIPTAN
OTC/RX Status: RX

Application #: 020589 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: CHILDREN’S ADVIL
Dosage Form: SUSPENSION
Applicant: WHITEHALL-ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFAN
OTC/RX Status: OTC

Application #: 020597 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: XALATAN
Dosage Form: SOLUTION
Applicant: PHARMACIA & UPJOHN COMPANY
Active Ingredient(s): LATANOPROST
OTC/RX Status: RX

Application #: 019012 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 25-AUG-00
Trade Name: MOTRIN IB
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 020869 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 24-AUG-00
Trade Name: COSOPT
Dosage Form: SOLUTION
Applicant: MERCK & CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 012665 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 24-AUG-00
Trade Name: VELBAN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND COMPANY
Active Ingredient(s): VINBLASTINE SULFATE
OTC/RX Status: RX

Application #: 020267 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 23-AUG-00
Trade Name: JUNIOR STRENGTH ADVIL
Dosage Form: TABLET
Applicant: WHITEHALL-ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 014684 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 23-AUG-00
Trade Name: AVENTYL HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 014684 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 23-AUG-00
Trade Name: AVENTYL HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 014685 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 23-AUG-00
Trade Name: AVENTYL HCL
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 014685 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 23-AUG-00
Trade Name: AVENTYL HCL
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019643 Labeling Supplement#: 059
To Original New Drug Application
Approval Date: 22-AUG-00
Trade Name: LOVASTATIN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Application #: 019766 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 22-AUG-00
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): SIMVASTATIN
OTC/RX Status: RX

Application #: 020883 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 22-AUG-00
Trade Name: ACOVA
Dosage Form: INJECTABLE
Applicant: TEXAS BIOTECHNOLOGY CORP
Active Ingredient(s): ARGATROBAN
OTC/RX Status: RX

Application #: 018869 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 22-AUG-00
Trade Name: NIMOTOP
Dosage Form: CAPSULE
Applicant: BAYER CORPORATION PHARMACEUTICAL DIVISION
Active Ingredient(s): NIMODIPINE
OTC/RX Status: RX

Application #: 020280 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 18-AUG-00
Trade Name: GENOTROPIN PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 116
To Original New Drug Application
Approval Date: 18-AUG-00
Trade Name: AZULFIDINE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 019651 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 14-AUG-00
Trade Name: ASACOL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 019651 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 14-AUG-00
Trade Name: ASACOL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 021107 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-AUG-00
Trade Name: LOTRONEX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALOSETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019721 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-AUG-00
Trade Name: NORDITROPIN
Dosage Form: INJECTABLE
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): SOMATROPIN RECOMBINANT
OTC/RX Status: RX

Application #: 020933 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 10-AUG-00
Trade Name: VIRAMUNE
Dosage Form: SUSPENSION
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX

Application #: 020636 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 10-AUG-00
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX

Application #: 020622 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 09-AUG-00
Trade Name: COPAXONE
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): GLATIRAMER ACETATE
OTC/RX Status: RX

Application #: 020243 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 09-AUG-00
Trade Name: LUVOX
Dosage Form: TABLET
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

Application #: 018960 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 03-AUG-00
Trade Name: CUPRIC CHLORIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): CUPRIC CHLORIDE
OTC/RX Status: RX

Application #: 019963 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 01-AUG-00
Trade Name: RENOVA
Dosage Form: EMULSION, CREAM
Applicant: JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX