Lepirudan (rDNA) for injection receives FDA "non-approvable" letter May 11 for treatment of anticoagulation in patients with acute coronary syndrome. The supplemental application was turned down by an FDA advisory committee May 2 (1"The Pink Sheet" May 8, p. 29). There are no ongoing or planned Refludan trials at this time, Aventis said
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Aventis was unable to convince FDA and its Cardiovascular & Renal Drugs Advisory Committee that its thrombin inhibitor Refludan is superior to placebo in the treatment of acute coronary syndromes by inference from historical data comparing heparin and placebo.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
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