FDA to discuss resubmitted Aveed NDA

FDA's Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees will meet on April 18 to discuss a resubmitted NDA from Endo Health Solutions Inc. (NASDAQ:ENDP) for Aveed testosterone undecanoate to treat male hypogonadism. Endo resubmitted the NDA last November. The company said the PDUFA date is in May, but has not disclosed a specific date.

According to the meeting notice, the safety discussion will focus on postmarketing reports of pulmonary oil embolism and potential anaphylactic reactions. In a 2009 complete response letter, FDA had requested information on serious adverse events, including oil embolism and anaphylactic reactions (see BioCentury Extra, Dec. 3, 2009). ...