Endo Pharmaceuticals has received a complete response letterfrom the FDA regarding the New DrugApplication (NDA) for its extended-duration testosterone undecanoateinjection, AVEED(TM), for men diagnosed with low testosterone. Lowtestosterone is also known as hypogonadism. In the complete response letter, the FDA has requested information fromEndo to address the agency’s concerns regarding very rare but serious adverseevents, including post-injection anaphylactic reaction and pulmonary oilmicroembolism. The letter also specified that the proposed Risk Evaluation andMitigation Strategy (REMS) is not sufficient. Endo is currently evaluating the FDA’s complete response letter.
