Dr Reddy's Asks U.S. FDA To Bypass Blocks To Revlimid Generic
This article was originally published in PharmAsia News
Executive SummaryDr Reddy's Laboratories of India has asked U.S. FDA to take steps to allow it to bypass normal procedures and make a generic of U.S.-based Celgene's Revlimid (lenalidomide) for treating blood cancer. DRL faces two hurdles at the U.S. agency. Celgene has refused to give Dr Reddy's samples for testing for required bioequivalence testing, and the agency also is suspending approval of any generic while it conducts a risk evaluation and mitigation strategy on Revlimid. The agency is concerned about possible birth defects if expectant mothers take the drug. (Click here for more
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