Drug Approvals for September 2000

Definitions and Notes

Original New Drug Applications

Original Application #: 021248
Approval Date: 25-SEP-00
Trade Name: TRIXENOX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: CELL THERAPEUTICS INC
Active Ingredient(s): ARSENIC TRIOXIDE
OTC/RX Status: RX
Indication(s): For the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression

Original Application #: 021097
Approval Date: 21-SEP-00
Trade Name: VISICOL
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: INKINE PHARMACEUTICAL CO INC
Active Ingredient(s): SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PH OSPHATE, MONOBASIC, MONOHYDRATE
OTC/RX Status: RX
Indication(s): For cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age and older

Original Application #: 021149
Approval Date: 20-SEP-00
Trade Name: OVIDREL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): GONADOTROPIN, CHORIONIC HUMAN RECOMBINANT
OTC/RX Status: RX
Indication(s): For the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program. Also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Original Application #: 021251
Approval Date: 15-SEP-00
Trade Name: KALETRA
Chemical Type:
Therapeutic Potential:
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR
OTC/RX Status: RX
Indication(s): For the treatment of HIV-1 infection in adults and pediatric patients age six months and older

Original Application #: 021226
Approval Date: 15-SEP-00
Trade Name: KALETRA
Chemical Type:
Therapeutic Potential:
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR; RITONAVIR
OTC/RX Status: RX
Indication(s): For the treatment of HIV-1 infection in adults and pediatric patients age six months and older

Original Application #: 021093
Approval Date: 05-SEP-00
Trade Name: ATACAND HCT
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ASTRAZENECA LP
Active Ingredient(s): CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Indication(s): For the treatment of hypertension

Efficacy Supplemental New Drug Applications

Application #: 020560 Efficacy Supplement#: 023
Type: SE1 to Original New Drug Application
Approval Date: 29-SEP-00
Trade Name: FOSAMAX
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): ALENDRONATE SODIUM
OTC/RX Status: RX
Efficacy Claim: For the treatment to increase bone mass in men with osteoporosis

Application #: 020496 Efficacy Supplement #: 005
Type: SE8 to Original New Drug Application
Approval Date: 27-SEP-00
Trade Name: AMARYL
Dosage Form: TABLETS
Applicant: AVENTIS PHARMACEUTICALS, INC
Active Ingredient(s): GLIMEPIRIDE
OTC/RX Status: RX
Efficacy Claim: Indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone

Application #: 020114 Efficacy Supplement#: 006
Type: SE5 to Original New Drug Application
Approval Date: 15-SEP-00
Trade Name: ASTELIN
Dosage Form: SPRAY, METERED
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): AZELASTINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of symptoms of vasomotor rhinitis in adults and children 12 years of age and older

Application #: 020635 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 08-SEP-00
Trade Name: LEVAQUIN
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of complicated skin and skin structure infections

Application #: 020634 Efficacy Supplement#: 013
Type: SE1 to Original New Drug Application
Approval Date: 08-SEP-00
Trade Name: LEVAQUIN
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): LEVOFLOXACIN
OTC/RX Status: RX
Efficacy Claim:For the treatment of complicated skin and skin structure infections

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075103
Approval Date: 29-SEP-00
Trade Name: HYDROCODONE BITARTRATE AND PHENYLPROPANOLAMINE HYDROCHLORIDE
Dosage Form: SYRUP
Applicant: ALPHARMA USPD INC
Active Ingredient(s): HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040315
Approval Date: 29-SEP-00
Trade Name: TROPICAMIDE
Dosage Form: SOLUTION
Applicant: AKORN, INC
Active Ingredient(s): TROPICAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 040314
Approval Date: 29-SEP-00
Trade Name: TROPICAMIDE
Dosage Form: SOLUTION
Applicant: AKORN, INC
Active Ingredient(s): TROPICAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075446
Approval Date: 28-SEP-00
Trade Name: BETAXOLOL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): BETAXOLOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075632
Approval Date: 27-SEP-00
Trade Name: BISOPR0LOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075289
Approval Date: 27-SEP-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application # 075768
Approval Date: 25-SEP-00
Trade Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN LABORATORIES INC
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075672
Approval Date: 25-SEP-00
Trade Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Application # 075527
Approval Date: 25-SEP-00
Trade Name: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application#065056
Approval Date: 18-SEP-00
Trade Name: AMOXICILLIN
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX

Original Abbreviated Application#075184
Approval Date: 15-SEP-00
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Original Abbreviated Application#065051
Approval Date: 11-SEP-00
Trade Name: CEFOXITIN
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE
Active Ingredient(s): CEFOXITIN
OTC/RX Status: RX

Original Abbreviated Application # 040405
Approval Date: 08-SEP-00
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075292
Tentative Approval Date: 01-SEP-00
Trade Name: FLUOXETINE HYDROCHLORIDE
Dosage Form: SOLUTION
Applicant: NU PHARM INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020857 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 29-SEP-00
Trade Name: COMBIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX

Application #: 018140 Labeling Supplement #: 026
To Original New Drug Application
Approval Date: 26-SEP-00
Trade Name: ATIVAN
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX

Application #: 007073 Labeling Supplement#: 118
To Original New Drug Application
Approval Date: 26-SEP-00
Trade Name: AZULFIDINE EN
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX

Application #: 050536 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 22-SEP-00
Trade Name: ERYC
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: FH FAULDING AND CO LTD
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX

Application #: 018651 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 22-SEP-00
Trade Name: MARINOL
Dosage Form: CAPSULE
Applicant: UNIMED INC
Active Ingredient(s): DRONABINOL
OTC/RX Status: RX

Application #: 020444 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 21-SEP-00
Trade Name: FLOLAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): EPOPROSTENOL SODIUM
OTC/RX Status: RX

Application #: 018920 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 21-SEP-00
Trade Name: M.V.I. PEDIATRIC
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA LP
Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE
OTC/RX Status: RX

Application #: 050679 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 20-SEP-00
Trade Name: MAXIPIME
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFEPIME HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020758 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 20-SEP-00
Trade Name: AVALIDE
Dosage Form: TABLET
Applicant:BRISTOL-MYERS SQUIBB
Active Ingredient(s): IRBESARTAN; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020757 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 20-SEP-00
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant: BRISTOL-MYERS SQUIBB
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX

Application #: 020144 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 20-SEP-00
Trade Name: TRANSDERM-NITRO
Dosage Form: FILM
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Application #: 020408 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 18-SEP-00
Trade Name: TRUSOPT
Dosage Form: SOLUTION, DROPS
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): DORZOLAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020330 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 18-SEP-00
Trade Name: TIMOPTIC-XE
Dosage Form: SOLUTION
Applicant: MERCK & CO., INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX

Application #: 020819 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 13-SEP-00
Trade Name: ZEMPLAR
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): PARICALCITOL
OTC/RX Status: RX

Application #: 020241 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 08-SEP-00
Trade Name: LAMICTAL
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMOTRIGINE
OTC/RX Status: RX

Application #: 019715 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 08-SEP-00
Trade Name: DIPENTUM
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): OLSALAZINE SODIUM
OTC/RX Status: RX

Application #: 020812 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 07-SEP-00
Trade Name: PEDIATRIC ADVIL
Dosage Form: SUSPENSION, DROPS
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Application #: 020802 Labeling Supplement #: 004
To Original New Drug Application
Approval Date: 07-SEP-00
Trade Name: EXCEDRIN (MIGRAINE)
Dosage Form: TABLET
Applicant: BRISTOL MYERS PRODUCTS INC
Active Ingredient(s): CAFFEINE; ACETAMINOPHEN; ASPIRIN
OTC/RX Status: OTC

Application #: 017007 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 06-SEP-00
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX

Application #: 016997 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 06-SEP-00
Trade Name: SERENTIL
Dosage Form: CONCENTRATE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 016775 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 06-SEP-00
Trade Name: SERENTIL
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 016774 Labeling Supplement #: 072
To Original New Drug Application
Approval Date: 06-SEP-00
Trade Name: SERENTIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 009386 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 06-SEP-00
Trade Name: MYLERAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUSULFAN
OTC/RX Status: RX

Application #: 021117 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 01-SEP-00
Trade Name: CALCIUM CHLORIDE 10%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): CALCIUM CHLORIDE
OTC/RX Status: RX