Biotech Tracker News - Zavesca Launched in the U.K. - - - - BioNews BioWeb Companies Products BioReports - - - - - - Biotech Tracker News - Zavesca Launched in the U.K.- March 03, 2003 Actelion (Swiss: ATLN) launched Zavesca (miglustat) in the United Kingdom.Zavesca throughout the European Union in the near future.Zavesca ’s overall risk/benefit ratio and...
Zavesca NDA Amendment Submitted - - - - BioNews BioWeb Companies Products BioReports - - - - - - Biotech Tracker News - Zavesca NDA Amendment March 26, 2003 Oxford GlycoSciences (NASDAQ: OGSI) submitted an amendment to its Zavesca (miglustat) NDA.Zavesca label.- In March, Actelion (Swiss:...
Drug Approvals - Z Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066 7/2/99 7/6/99 7/6/99 3/31/02 ZADITOR (ketotifen fumarate ophthalmic solution) 0.025%, Rx Ciba Vision NDA 21-066/S4 07/20/01 05/08/03 - ZADITOR Indication: for the prevention of itching of the eye due to allergic...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Zavesca (Miglustat) Capsules Company:- Actelion Pharmaceuticals Application No.:- 021348 Approval Date:-7/31/2003 Approval Letter(s) - - Printed Labeling - - Medical Review(s) Part 1 - Part 2 - Part 3 - Part 4 - Part 5 - Part 6 - Part 7 - Chemistry Review(s) - - Pharmacology...
Approved Biotechnology Drugs, 2002 Biotechnology Information, Advocacy and Business Support | About Us | BIO Events | BIO Members | Join BIO | Member Services | Links | Home CMS Payment System Prescription Coverage & Reimbursement Food & Agriculture Industrial & Environmental Bioethics & Biomedical Research Intellectual Property Regulatory Policies Tax & Fiscal Policies All Issues & Initiatives Press Releases Company...
Prescription and Over-the-Counter Drug Product List: 7/2003 >A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001...
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FY 2003 NDA Approvals for New Molecular Entities FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -FY 2003 NDA Approvals for New Molecular Entities as of September 30, 2003 NDA # Trade Name (Generic Name) Dosage Form Applicant Date of- Approval Class Indication(s) 21-445 Zetia------ (ezetimibe)-- Tablets MSP Singapore -25-Oct-02 1S Zetia is indicated for (1) Primary hypercholesterolemia ...
Fast Track Designated Products Approved since 1998 FAST TRACK DESIGNATED PRODUCTS APPROVED SINCE 1998 Through September 30, 2003 - NDA# NDA Drug Name Sponsor Applicant Approval Date Indication N020972 Sustiva (Efavirenz) 50/ 100/ 200MG Caps Dupont Pharms 9/17/98 Treatment of HIV N20977 Ziagen (Abacavir Sulfate) Tablets Glaxo Wellcome 12/17/98 Treatment of HIV N20978 Ziagen (Abacavir Sulfate) Oral Solution 12/17/98 N21007 Agenerase ...
author: Michael Lanthier
Zavesca Consumer Information Zavesca ® Brand Name: Zavesca ® Active Ingredient: - miglustat Strength(s): 100 mg Dosage Form(s): - Capsule Company Name: -- Galen Limited; Actelion Pharmaceuticals US IncZavesca is used to treat adults with mild to moderate type I Gaucher diseasemiglustat Zavesca: Do not get...
zavescaAPPROV.PDF ZAVESCA ® (Miglustat; OGT 918) Label Version 6.4: Updated 31- July 2003 6 Liver volume results from Studies 1 and 2 and their extensions are summarized in Table 1: Table 1: Liver Volume Changes in 2 Open- Label Uncontrolled Monotherapy Studies of ZAVESCA ® with Extension Phases Liver Volume n Absolute Mean (L) (2- sided 95% CI) Percent Mean (%) (2- sided 95%...
author: MADARAP
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