Endo receives complete response for testosterone therapy

Endo Health Solutions Inc. (NASDAQ:ENDP) said FDA issued a complete response letter for a resubmitted NDA for Aveed testosterone to treat male hypogonadism. The company said FDA 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." Endo said FDA did not request additional clinical studies, but the company declined to disclose details. Endo said it plans to submit a response to FDA by the end of next quarter.

Last month, FDA's Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees voted 1-17 against Endo's proposed instructions for use of Aveed, which included administering the product with a 30-60 second injection and requiring patients to remain in the doctor's office for 30 minutes post-injection. The committee voted 9-9 that Aveed was safe in the proposed indication. 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). ...