FDA to again review Endo's Aveed

FDA accepted for review a resubmitted NDA from Endo Health Solutions Inc. (NASDAQ:ENDP) for Aveed testosterone to treat male hypogonadism. The PDUFA date is Feb. 28, 2014. In May, FDA issued a complete response letter for Aveed and requested that Aveed's REMS include a medication guide and elements to assure safe use (ETASU) "to mitigate the risks and severe complications related to post-injection reactions" (see BioCentury Extra, May 30). ...