Drug Approvals for January 1997

Definitions and Notes

January 1997

Original New Drug Applications

Original Application #: 050733
Approval Date: 30-JAN-97
Trade Name: ZITHROMAX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN
OTC/RX Status: RX
Indication(s): Treatment of patients with community-acquired pneumonia and pelvic inflammatiory disease in patients who require initial intravenous therapy

Original Application #: 020720
Approval Date: 29-JAN-97
Trade Name: REZULIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Indication(s): For use in Type II diabetes patients whose hyperglycemia is inadequately controlled despite insulin therapy

Original Application #: 020719
Approval Date: 29-JAN-97
Trade Name: PRELAY
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: SANKYO USA CORP
Active Ingredient(s): TROGLITAZONE
OTC/RX Status: RX
Indication(s): For use in Type II diabetes patients whose hyperglycemia is inadequately controlled despite insulin therapy

Original Application #: 020458
Approval Date: 28-JAN-97
Trade Name: GALZIN
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): ZINC ACETATE
OTC/RX Status: RX
Indication(s): Maintenance treatment for patients with Wilson's disease initially treated with a chelating agent

Original Application #: 020605
Approval Date: 24-JAN-97
Trade Name: ZOFRAN
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Prevention of nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative

Original Application #: 020404
Approval Date: 14-JAN-97
Trade Name: AVITA
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: PENEDERM INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX
Indication(s): Treatment of acne vulgaris

Original Application #: 020463
Approval Date: 03-JAN-97
Trade Name: NASALCROM
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: SPRAY, METERED
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: OTC
Indication(s): For the prevention and relief of the nasal symptoms of hayfever and other nasal allergies in adults and in children 6 years of age and older

Efficacy Supplemental New Drug Applications

Application #: 020239EfficacySupplement#:004
Type: SE2 to Original New Drug Application
Approval Date: 21-JAN-97
Trade Name: KYTRIL
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Provides for a 30 second infusion as an alternate regimen to the currently approved 5 minute infusion time

Application #: 020192 Efficacy Supplement #: 003
Type: SE1 to Original New Drug Application
Approval Date: 21-JAN-97
Trade Name: LAMISIL
Dosage Form: CREAM
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of plantar tinea pedis (moccasin type)

Application #:050662Efficacy Supplement #:015
Type: SE1 to Original New Drug Application
Approval Date: 16-JAN-97
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: Use in combination with ranitidine bismuth citrate for the treatment of patients with an active duodenal ulcer associated with Helicobacter pylori infection

Application #: 018705 Efficacy Supplement #: 006
Type: SE4 to Original New Drug Application
Approval Date: 10-JAN-97
Trade Name: NITROLINGUAL
Dosage Form: SPRAY, METERED
Applicant: G POHL BOSKAMP GMBH AND CO
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX
Efficacy Claim: Provides for a chlorofluorocarbon-free formation with a mechanical pumpspray delivery system and for changing the name of the product to Nitrolingual Pumpspray

Approvable Original New Drug Applications

Original Application #: 020333
Approvable Date: 29-JAN-97
Trade Name: AGRYLIN
Dosage Form: CAPSULE
Applicant: ROBERTS PHARMACEUTICAL
Active Ingredient(s): ANAGRELIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020400
Approvable Date: 14-JAN-97
Trade Name: AVITA
Dosage Form: GEL
Applicant: PENEDERM INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Original Application #: 020658
Approvable Date: 02-JAN-97
Trade Name: REQUIP
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): ROPINIROLE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 073599
Approval Date: 30-JAN-97
Trade Name: REPRONAL
Dosage Form: INJECTABLE
Applicant: FERRING PHARMACEUTICALS INC
Active Ingredient(s): MENOTROPINS
OTC/RX Status: RX

Original Abbreviated Application # 073598
Approval Date: 30-JAN-97
Trade Name: REPRONAL
Dosage Form: INJECTABLE
Applicant: FERRING PHARMACEUTICALS INC
Active Ingredient(s): MENOTROPINS
OTC/RX Status: RX

Original Abbreviated Application # 040179
Approval Date: 30-JAN-97
Trade Name: MECLIZINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): MECLIZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074796
Approval Date: 27-JAN-97
Trade Name: GUANFACINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): GUANFACINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074744
Approval Date: 27-JAN-97
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074553
Approval Date: 27-JAN-97
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040149
Approval Date: 27-JAN-97
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074768
Approval Date: 23-JAN-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: OHMEDA PHARMACEUTICAL PRODUCTS DIV INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074753
Approval Date: 23-JAN-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: OHMEDA PHARMACEUTICAL PRODUCTS DIV INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074626
Approval Date: 23-JAN-97
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074620
Approval Date: 22-JAN-97
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES DIAGNOSTICS DIV
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074736
Approval Date: 21-JAN-97
Trade Name: PENTAZOCINE AND NALOXONE HYDROCHLORIDES
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE DE
OTC/RX Status: RX

Original Abbreviated Application # 074479
Approval Date: 21-JAN-97
Trade Name: ALPRAZOLAM
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ALPRAZOLAM
OTC/RX Status: RX

Original Abbreviated Application # 074661
Approval Date: 13-JAN-97
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074646
Approval Date: 13-JAN-97
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 074635
Approval Date: 13-JAN-97
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040165
Approval Date: 13-JAN-97
Trade Name: CYCLOPENTOLATE HCL
Dosage Form: SOLUTION/DROPS
Applicant: AKORN INC
Active Ingredient(s): CYCLOPENTOLATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040164
Approval Date: 13-JAN-97
Trade Name: CYCLOPENTOLATE HCL
Dosage Form: SOLUTION/DROPS
Applicant: AKORN INC
Active Ingredient(s): CYCLOPENTOLATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074755
Approval Date: 10-JAN-97
Trade Name: IPRATROPIUM BROMIDE MONOHYDRATE
Dosage Form: SOLUTION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074710
Tentative Approval Date : 09-JAN-97
Trade Name: TERFENADINE
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredients(s): TERFENADINE
OTC/RX Status: RX

Original Abbreviated Application # 074475
Approval Date: 03-JAN-97
Trade Name: TERFENADINE
Dosage Form: TABLET
Applicant: BAKER NORTON PHARMACEUTICALS INC
Active Ingredient(s): TERFENADINE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074662
Tentative Approval Date: 31-JAN-97
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074552
Tentative Approval Date: 31-JAN-97
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074792
Tentative Approval Date: 27-JAN-97
Trade Name: GLYBURIDE (MICRONIZED)
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Original Application #: 020400
Tentative Approval Date: 14-JAN-97
Trade Name: AVITA
Dosage Form: GEL
Applicant: PENEDERM INC
Active Ingredient(s): TRETINOIN
OTC/RX Status: RX

Application #: 074710
Tentative Approval Date : 09-JAN-97
Drug Name: TERFENADINE
Applicant: PAR PHARMACEUTICAL INC

Original Abbreviated Application #: 074301
Tentative Approval Date: 09-JAN-97
Trade Name: TERFENADINE
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): TERFENADINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #:020246LabelingSupplement#: 011 To Original New Drug Application
Approval Date: 31-JAN-97
Trade Name: DEPO-PROVERA
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Application #:018701LabelingSupplement#: 029 To Original New Drug Application
Approval Date: 31-JAN-97
Trade Name: HALDOL DECANOATE
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): HALOPERIDOL
OTC/RX Status: RX

Application #:020164LabelingSupplement#: 014 To Original New Drug Application
Approval Date: 27-JAN-97
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX

Application #:020239LabelingSupplement#: 002 To Original New Drug Application
Approval Date: 21-JAN-97
Trade Name: KYTRIL
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX

Application #:019384LabelingSupplement#: 031 To Original New Drug Application
Approval Date: 15-JAN-97
Trade Name: NOROXIN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Application #:020487LabelingSupplement#: 004 To Original New Drug Application
Approval Date: 13-JAN-97
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX

Application #:020263LabelingSupplement#: 009 To Original New Drug Application
Approval Date: 10-JAN-97
Trade Name: LUPRON DEPOT-PED
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX

Application #:020051LabelingSupplement#: 008 To Original New Drug Application
Approval Date: 10-JAN-97
Trade Name: GLYNASE
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): GLYBURIDE
OTC/RX Status: RX

Application #:019129LabelingSupplement#: 028 To Original New Drug Application
Approval Date: 10-JAN-97
Trade Name: MAXZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): TRIAMTERENE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #:019091LabelingSupplement#: 005 To Original New Drug Application
Approval Date: 10-JAN-97
Trade Name: ISMO
Dosage Form: TABLET
Applicant: WYETH LABORATORIES INC
Active Ingredient(s): ISOSORBIDE MONONITRATE
OTC/RX Status: RX

Application #:050630LabelingSupplement#: 011 To Original New Drug Application
Approval Date: 09-JAN-97
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX

Application #:050587LabelingSupplement#: 045 To Original New Drug Application
Approval Date: 09-JAN-97
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX

Application #:020563LabelingSupplement#: 001 To Original New Drug Application
Approval Date: 09-JAN-97
Trade Name: HUMALOG
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN LISPRO
OTC/RX Status: RX

Application #:050356LabelingSupplement#: 043 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: COLY-MYCIN S
Dosage Form: SUSPENSION/DROPS
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE
OTC/RX Status: RX

Application #:020680LabelingSupplement#: 005 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #:020659LabelingSupplement#: 005 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #:020184LabelingSupplement#: 003 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ACEON
Dosage Form: TABLET
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): PERINDOPRIL ERBUMINE
OTC/RX Status: RX

Application #:020089LabelingSupplement#: 010 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ZOVIRAX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:019915LabelingSupplement#: 021 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: MONOPRIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): FOSINOPRIL SODIUM
OTC/RX Status: RX

Application #:019909LabelingSupplement#: 011 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ZOVIRAX
Dosage Form: SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:019787LabelingSupplement#: 013 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: NORVASC
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): AMLODIPINE BESYLATE
OTC/RX Status: RX

Application #:019777LabelingSupplement#: 032 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ZESTRIL
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Application #:019684LabelingSupplement#: 012 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: PROCARDIA XL
Dosage Form: TABLET
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Application #:019028LabelingSupplement#: 009 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: PERIDEX
Dosage Form: SOLUTION
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX

Application #:019028LabelingSupplement#: 008 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: PERIDEX
Dosage Form: SOLUTION
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX

Application #:019028LabelingSupplement#: 007 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: PERIDEX
Dosage Form: SOLUTION
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX

Application #:018828Labeling Supplement#:019 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ZOVIRAX
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:018604Labeling Supplement#:014 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: ZOVIRAX
Dosage Form: OINTMENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #:017943LabelingSupplement#: 014 To Original New Drug Application
Approval Date: 08-JAN-97
Trade Name: PROLOPRIM
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): TRIMETHOPRIM
OTC/RX Status: RX

Application #:020571LabelingSupplement#: 001 To Original New Drug Application
Approval Date: 03-JAN-97
Trade Name: CAMPTOSAR
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): IRINOTECAN HYDROCHLORIDE
OTC/RX Status: RX