Drug Approvals for March 1999

Definitions and Notes

March 1999

Original New Drug Applications

Original Application #: 020966
Approval Date: 30-MAR-99
Trade Name: SPORANOX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Indication(s): For the treatment of blastomycosis, histoplasmosis and aspergillosis in immunocompromised and non-immunocompromised patients

Original Application #: 020908
Approval Date: 26-MAR-99
Trade Name: VAGIFEM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVO NORDISK PHARMACEUTICAL INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): For the relief of postmenopausal atrophic vaginitis due to estrogen deficiency

Original Application #: 020837
Approval Date: 25-MAR-99
Trade Name: XOPENEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: SEPRACOR PHARMACEUTICALS
Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment or prevention of bronchospasm in adults and adolescents 12 years of age and older with reversible obstructive airway disease

Original Application #: 020992
Approval Date: 24-MAR-99
Trade Name: CENESTIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): ESTROGENS, CONJUGATED
OTC/RX Status: RX
Indication(s): For use in the treatment of moderate-to-severe vasomotor symptoms associated with the menopause

Original Application #: 020612
Approval Date: 19-MAR-99
Trade Name: LIDODERM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: FILM, EXTENDED RELEASE
Applicant: HIND HEALTH CARE
Active Ingredient(s): LIDOCAINE
OTC/RX Status: RX
Indication(s): For the treatment of pain in post-herpatic neuralgia

Original Application #: 020980
Approval Date: 09-MAR-99
Trade Name: LAMISIL
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: EMULSION, CREAM
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: OTC
Indication(s): For the treatment of tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm) due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum

Original Application #: 020994
Approval Date: 05-MAR-99
Trade Name: CLIMARA
Chemical Type: 6
Therapeutic Potential: S
Dosage Form:FILM, EXTENDED RELEASE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s):For the prevention of postmenopausal osteoporosis (loss of bone mass)

Efficacy Supplemental New Drug Applications

Application #: 020287 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 30-MAR-99
Trade Name: FRAGMIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): DALTEPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the use of Fragmin for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism, in patients undergoing hip replacement surgery

Application #: 020699 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 11-MAR-99
Trade Name: EFFEXOR XR
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of generalized anxiety disorder as a new indication

Application #: 019643 Efficacy Supplement#: 055
Type: SE1 to Original New Drug Application
Approval Date: 11-MAR-99
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Efficacy Claim: For use in the primary prevention of coronary heart disease in patients without symptomatic cardiovascular disease who have average to moderately elevated total-C and LDL-C and below average HDL-C

Application #: 020745 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: ZANTAC 75
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC
Efficacy Claim: For the prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages

Application #: 020261 Efficacy Supplement #: 018
Type: SE1 to Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the reduction of triglycerides and ApoB in patients with primary hypercholesterolemia and mixed dyslipidemia

Approvable Original New Drug Applications

Original Application #: 020949
Approvable Date: 30-MAR-99
Trade Name: ACCUVENT
Dosage Form: SOLUTION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Application #: 020982
Approvable Date: 10-MAR-99
Trade Name: PAXIL CR
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020931
Approvable Date: 05-MAR-99
Trade Name: TIKOSYN
Dosage Form: CAPSULE
Applicant: PFIZER CHEMICAL CORP
Active Ingredient(s): DOFETILIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074962
Approval Date: 31-MAR-99
Trade Name: PENTOXIFYLLINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: UPSHER SMITH LABORATORIES INC
Active Ingredient(s): PENTOXIFYLLINE
OTC/RX Status: RX

Original Abbreviated Application # 075262
Approval Date: 30-MAR-99
Trade Name: ALBUTEROL SULFATE
Dosage Form: SYRUP
Applicant: UDL LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 074723
Approval Date: 30-MAR-99
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, DELAYED RELEASE
Applicant: NOVOPHARM LTD
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075327
Approval Date: 24-MAR-99
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Applications065005
Approval Date: 23-MAR-99
Trade Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: GLOBAL PHARMACEUTICAL CORP
Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074707
Approval Date: 19-MAR-99
Trade Name: NICOTINE POLACRILEX
Dosage Form: GUM, CHEWING
Applicant: CIRCA PHARMACEUTICALS INC
Active Ingredient(s): NICOTINE POLACRILEX
OTC/RX Status: RX

Original Abbreviated Antibiotic Applications040289
Approval Date: 16-MAR-99
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): OXYCODONE AND ACETAMINOPHEN
OTC/RX Status: RX

Original Abbreviated Application # 074507
Approval Date: 15-MAR-99
Trade Name: NICOTINE POLACRILEX
Dosage Form: GUM, CHEWING
Applicant: CIRCA PHARMACEUTICALS INC
Active Ingredient(s): NICOTINE POLACRILEX
OTC/RX Status: RX

Original Abbreviated Application # 040203
Approval Date: 15-MAR-99
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040305
Approval Date: 10-MAR-99
Trade Name: MEPERIDINE HCL
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075351
Approval Date: 05-MAR-99
Trade Name: ASPIRIN, BUTALBITAL, CAFFEINE AND CODEINE PHOSPHATE
Dosage Form: CAPSULE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): ASPIRIN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 075139
Approval Date: 01-MAR-99
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: LNK INTERNATIONAL INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 075010
Approval Date: 01-MAR-99
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: LNK INTERNATIONAL INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

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

Original Abbreviated Application #: 075277
Tentative Approval Date: 29-MAR-99
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: ESI LEDERLE INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application #: 074876
Tentative Approval Date: 24-MAR-99
Trade Name: CIPROFLOXACIN HYDROCLORIDE
Dosage Form: TABLET
Applicant: NOVOPHARM PHARMACEUTICAL CO
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075108
Tentative Approval Date: 15-MAR-99
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application #: 075254
Tentative Approval Date: 10-MAR-99
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Original Abbreviated Application #: 074732
Tentative Approval Date: 09-MAR-99
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Original Abbreviated Application #: 074539
Tentative Approval Date: 09-MAR-99
Trade Name: TAMOXIFIEN CITRATE
Dosage Form: TABLET
Applicant: PHARMACHEMIE BV
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX

Original Abbreviated Application #: 075048
Tentative Approval Date: 05-MAR-99
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020747 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 26-MAR-99
Trade Name: ACTIQ
Dosage Form: TROCHE/LOZENGE
Applicant: ANESTA CORP
Active Ingredient(s): FENTANYL CITRATE
OTC/RX Status: RX

Application #: 012151 Labeling Supplement#: 060
To Original New Drug Application
Approval Date: 26-MAR-99
Trade Name: ALDACTONE
Dosage Form: TABLET
Applicant: SEARLE PHARMACEUTICALS INC
Active Ingredient(s): SPIRONOLACTONE
OTC/RX Status: RX

Application #: 019797 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 25-MAR-99
Trade Name: NuLYTELY
Dosage Form: SOLUTION
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
OTC/RX Status: RX

Application #: 019011 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 25-MAR-99
Trade Name: GoLYTELY
Dosage Form: SOLUTION
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE,ANHYDROUS
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 23-MAR-99
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME, INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 23-MAR-99
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME, INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020597 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 22-MAR-99
Trade Name: XALATAN
Dosage Form: SOLUTION, DROPS
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LATANOPROST
OTC/RX Status: RX

Application #: 011355 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 19-MAR-99
Trade Name: ENDRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): EDETATE DISODIUM
OTC/RX Status: RX

Application #: 020752 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 18-MAR-99
Trade Name: PEPCID RPD
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 020249 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 18-MAR-99
Trade Name: PEPCID
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019527 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 18-MAR-99
Trade Name: PEPCID
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019510 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 18-MAR-99
Trade Name: PEPCID
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 019462 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 18-MAR-99
Trade Name: PEPCID
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 020607 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 17-MAR-99
Trade Name: ARTHROTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL
OTC/RX Status: RX

Application #: 020547 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 17-MAR-99
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ZENECA LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX

Application #: 019268 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 17-MAR-99
Trade Name: CYTOTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): MISOPROSTOL
OTC/RX Status: RX

Application #: 017963 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 16-MAR-99
Trade Name: LOPRESSOR
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METOPROLOL TARTRATE
OTC/RX Status: RX

Application #: 020221 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 11-MAR-99
Trade Name: ETHYOL
Dosage Form: INJECTABLE
Applicant: US BIOSCIENCE INC
Active Ingredient(s): AMIFOSTINE
OTC/RX Status: RX

Application #: 020403 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 10-MAR-99
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020007 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 10-MAR-99
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018821 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 09-MAR-99
Trade Name: REGLAN
Dosage Form: SYRUP
Applicant: WYETH-AYERST LABORATORIES
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017862 Labeling Supplement#: 042
To Original New Drug Application
Approval Date: 09-MAR-99
Trade Name: REGLAN
Dosage Form: INJECTABLE
Applicant: WYETH-AYERST LABORATORIES
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017854 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 09-MAR-99
Trade Name: REGLAN
Dosage Form: TABLET
Applicant: WYETH-AYERST LABORATORIES
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020857 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: COMBIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 08-MAR-99
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 017694 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 01-MAR-99
Trade Name: IMODIUM
Dosage Form: CAPSULE
Applicant: JANSSEN PHARMACEUTICA INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: RX