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Drug Approvals for December 1999
Definitions and Notes
Original New Drug Applications
Original Application #: 021055
Approval Date: 29-DEC-99
Trade Name: TARGRETIN
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: LIGAND PHARMACEUTICALS INC
Active Ingredient(s): BEXAROTENE
OTC/RX Status: RX
Indication(s): For the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
Application #:020601 Labeling Supplement#:005 To Original New Drug Application
Approval Date: 29-DEC-99
Trade Name: CHILDREN'S MOTRIN
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Original Application #: 021156
Approval Date: 23-DEC-99
Trade Name: CELEBREX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: G.D. SEARLE & CO.
Active Ingredient(s): CELECOXIB
OTC/RX Status: RX
Indication(s): To reduce the number of adenomatous colorectal polyps in Familial Adenomatous Plyposis pateints, as an adjunct to usual care.
Original Application #: 020845
Approval Date: 23-DEC-99
Trade Name: INOMAX
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: INHALATION
Applicant: INO THERAPEUTICS INC
Active Ingredient(s): NITRIC OXIDE
OTC/RX Status: RX
Indication(s): For the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, where it improves oxygenation and reduces the need for extracorporeal membrane oxygenation
Original Application #: 021092
Approval Date: 17-DEC-99
Trade Name: HELICOSOL
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: METABOLIC SOLUTIONS INC
Active Ingredient(s): UREA, C-13
OTC/RX Status: RX
Indication(s): For the use of Helicosol lyophilized powder in conjunction with the Ez-HBT test for the detection of CO2 in whole blood specimens, collected after the ingestion of C-uera
Original Application #: 021062
Approval Date: 17-DEC-99
Trade Name: TEQUIN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX
Indication(s): For Community- Acquired Pneumonia; Acute Bacterial Exacerbation of Chronic Bronchitis; Acute Sinusitis; Uncomplicated Urinary Tract Infections; Complicated Urinary Tract Infections; and Pyelonephritis; Uncomplicated Urethal, Pharyngeal, and Rectal Gonorrhea in Males; as well as Endocervical, Pharyngeal, and Rectal Gonorrhea in Females
Original Application #: 021061
Approval Date: 17-DEC-99
Trade Name: TEQUIN
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX
Indication(s): For Community- Acquired Pneumonia; Acute Bacterial Exacerbation of Chronic Bronchitis; Acute Sinusitis; Uncomplicated Urinary Tract Infections; Complicated Urinary Tract Infections; and Pyelonephritis; Uncomplicated Urethal, Pharyngeal, and Rectal Gonorrhea in Males; as well as Endocervical, Pharyngeal, and Rectal Gonorrhea in Females
Original Application #: 021046
Approval Date: 22-DEC-99
Trade Name: CELEXA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): CITALOPRAM HYDROBROMIDE
OTC/RX Status: RX
Indication(s): For the treatment of depression
Original Application #: 021022
Approval Date: 17-DEC-99
Trade Name: PENLAC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CICLOPIROX
OTC/RX Status: RX
Indication(s): For the topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum
Original Application #: 020922
Approval Date: 10-DEC-99
Trade Name: SOLAGE
Chemical Type: 14
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEQUINOL; TRETINOIN
OTC/RX Status: RX
Indication(s): For the treatment of solar lentigines
Original Application #: 021085
Approval Date: 10-DEC-99
Trade Name: AVELOX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BAYER CORPORATION
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia.
Original Application #: 020976
Approval Date: 08-DEC-99
Trade Name: OPTIMARK
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT INC
Active Ingredient(s): GADOVERSETAMIDE
OTC/RX Status: RX
Indication(s): For the use of optimark with magnetic resonance imaging (MRI) in patients with an abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues; and with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on computerized tomography
Original Application #: 020975
Approval Date: 08-DEC-99
Trade Name: OPTIMARK
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT INC
Active Ingredient(s): GADOVERSETAMIDE
OTC/RX Status: RX
Indication(s): For the use of optimark with magnetic resonance imaging (MRI) in patients with an abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues; and with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on computerized tomography
Original Application #: 020937
Approval Date: 08-DEC-99
Trade Name: OPTIMARK
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT INC
Active Ingredient(s): GADOVERSETAMIDE
OTC/RX Status: RX
Indication(s): For the use of optimark with magnetic resonance imaging (MRI) in patients with an abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues; and with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities identified on computerized tomography
Original Application #: 020990
Approval Date: 07-DEC-99
Trade Name: ZOLOFT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CONCENTRATE
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): depression, OCD, and panic disorder.
Original Application #: 020965
Approval Date: 03-DEC-99
Trade Name: LEVULAN KERASTICK
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: GUIDELINES, INCORPORATED
Active Ingredient(s): AMINOLEVULINIC ACID HCL
OTC/RX Status: RX
Indication(s): For the use with a blue light irradiation using the BLU-U Illuminator for the photodynamic therapy of actinic keratoses of the face and scalp
Efficacy Supplemental New Drug Applications
Application #: 020449 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 23-DEC-99
Trade Name: TAXOTERE
Dosage Form: INJECTABLE
Applicant: RHONE-POULENC RORER
Active Ingredient(s): DOCETAXEL
OTC/RX Status: RX
Efficacy Claim: For the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy
Application #: 019839 Efficacy Supplement#: 026
Type: SE1 to Original New Drug Application
Approval Date: 07-DEC-99
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of post-traumatic stress disorder
Application #: 020762 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 02-DEC-99
Trade Name: NASONEX
Dosage Form: SPRAY, METERED
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE MONOHYDRATE
OTC/RX Status: RX
Efficacy Claim: For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in patients 3 to 11 years of age
Application #: 020702 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 02-DEC-99
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: WARNER LAMBERT EXPORT LTD
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Efficacy Claim: For the additional indication of increasing HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types Iia and Iib)
Application #: 019676 Efficacy Supplement#: 013
Type: SE8 to Original New Drug Application
Approval Date: 01-DEC-99
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENETECH, INC
Active Ingredient(s): SOMATROPIN
OTC/RX Status: RX
Efficacy Claim: For the improvement in spine bone mineral density observed in childhood-onset adult growth hormone deficient patients and for increases in serum alkaline phosphatase
Application #: 020522 Efficacy Supplement#: 009
Type: SE8 to Original New Drug Application
Approval Date: 01-DEC-99
Trade Name: NUTROPIN
Dosage Form: INJECTABLE
Applicant: GENETECH, INC
Active Ingredient(s): SOMATROPIN
OTC/RX Status: RX
Efficacy Claim: For the improvement in spine bone mineral density observed in childhood-onset adult growth hormone deficient patients and for increases in serum alkaline phosphatase
Original Abbreviated Application # 075597
Approval Date: 23-DEC-99
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX
Original Abbreviated Application # 065021
Approval Date: 23-DEC-99
Trade Name: AMOXICILLIN
Dosage Form: TABLET
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX
Original Abbreviated Application # 075116
Approval Date: 23-DEC-99
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074984
Approval Date: 20-DEC-99
Trade Name: DILTIAZEM HYDROCHLORIDE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: PUREPAC PHARMACEUTICALS CO.
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075406
Approval Date: 15-DEC-99
Trade Name: NORGESTREL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: SCS PHARMACEUTICALS
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX
Original Abbreviated Application # 040262
Approval Date: 15-DEC-99
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: PHARMACHEMIE BV
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX
Original Abbreviated Application # 075568
Approval Date: 13-DEC-99
Trade Name: AZATHIOPRINE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): AZATHIOPRINE
OTC/RX Status: RX
Original Abbreviated Application # 075172
Approval Date: 03-DEC-99
Trade Name: COLOCORT
Dosage Form: ENEMA
Applicant: PADDOCK LABORATORIES INC
Active Ingredient(s): HYDROCORTISONE ENEMA
OTC/RX Status: RX
Original Abbreviated Application # 040311
Approval Date: 01-DEC-99
Trade Name: MEDROXYPROGESTERONE ACETATE
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075413
Tentative Approval Date: 21-DEC-99
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020281 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 23-DEC-99
Trade Name: ULTRAM
Dosage Form: TABLET
Applicant: RW JOHNSON RESEARCH INSTITUTE
Active Ingredient(s): TRAMADOL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050716 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 21-DEC-99
Trade Name: NEORAL
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Application #: 050715 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 21-DEC-99
Trade Name: NEORAL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Application #: 050625 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 21-DEC-99
Trade Name: SANDIMMUNE
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Application #: 050574 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 21-DEC-99
Trade Name: SANDIMMUNE
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Application #: 050573 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 21-DEC-99
Trade Name: SANDIMMUNE
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Application #: 020035 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 20-DEC-99
Trade Name: ERGAMISOL
Dosage Form: TABLET
Applicant: JANSSEN PHARMACEUTICA INC
Active Ingredient(s): LEVAMISOLE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018869 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 15-DEC-99
Trade Name: NIMOTOP
Dosage Form: CAPSULE
Applicant: BAYER CORP
Active Ingredient(s): NIMODIPINE
OTC/RX Status: RX
Application #: 020262 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 10-DEC-99
Trade Name: TAXOL
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB COMPANY
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Application #: 020997 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 02-DEC-99
Trade Name: CHIROCAINE
Dosage Form: INJECTABLE
Applicant: DARWIN DISCOVERY LTD
Active Ingredient(s): LEVOBUPIVACAINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018874 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 02-DEC-99
Trade Name: CALCIJEX
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX
Application #: 019908 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 01-DEC-99
Trade Name: AMBIEN
Dosage Form: TABLET
Applicant: LOREX PHARMACEUTICALS
Active Ingredient(s): ZOLPIDEM TARTRATE
OTC/RX Status: RX
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Date created: March 08, 2001; last update: June 20, 2005 |
