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Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla HIV Treatment
Mylan, 08/19/09
Mylan Inc. announced that Matrix Laboratories, an Indian company in which Mylan owns a controlling stake, has received tentative approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its Abbreviated New Drug Application for a fixed–dose combination of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Tablets, 600 mg/200 mg/300 mg. This is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries.
Today in Drug Approvals...keeping you current
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Boston Scientific Announces FDA Clearance and CE Mark for WallFlex Fully Covered Esophageal Stent
Boston Scientific, 11/24/09
Dendreon Receives FDA Acknowledgement of Complete Response
Dendreon Coproration, 11/23/09
ImmunoGen, Inc. Announces Second License Taken by Amgen for Right to Use the Companys TAP Technology
ImmunoGen, Inc., 11/20/09
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Generic Anticonvulsant Use in Children: Do We Have Evidence to Recommend Brand Formulations?
Archives of Neurology, 11/23/09
Medtronic Receives FDA Warning Letter Following Inspection of Its Mounds View, Minn. Facility
Medtronic, 11/19/09
Therapy modifications and low-density lipoprotein cholesterol goal attainment rates associated with the initiation of generic simvastatin
Current Medical Research and Opinion, 11/17/09
Today in Other Drugs...keeping you current
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Persistence with injectable antidiabetic agents in members with type 2 diabetes in a commercial managed care organization
Current Medical Research and Opinion, 11/25/09
Anti-relapse medications: Preclinical models for drug addiction treatment
Pharmacology & Therapeutics, 11/25/09
Glibenclamide-related excess in total and cardiovascular mortality risks: Data from large Ukrainian observational cohort study
Diabetes Research and Clinical Practice, 11/25/09
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