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See Latest ArticlesU.S. FDA Issues Complete Response Letter for Rivaroxaban
BayNews International, 06/11/09
The U.S. Food and Drug Administration has issued a complete response letter for the new drug application for Bayer's rivaroxaban, a novel, oral anticoagulant taken as one tablet, once-daily. The NDA, filed in July 2008 by Bayer’s development partner Johnson and Johnson Pharmaceutical Research and Development, L.L.C. , seeks approval to market rivaroxaban, a first-in-class direct Factor Xa inhibitor, in the United States for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Today in Drug Approvals...keeping you current
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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/22/09
Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09
Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
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Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
Generic Anticonvulsant Use in Children: Do We Have Evidence to Recommend Brand Formulations?
Archives of Neurology, 11/23/09
FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Gen-Probe, 11/02/09
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