FDA Declines Approval of Testosterone Drug for Third Time

In May 2013, the FDA rejected Endo Pharmaceuticals' Aveed, a long-acting testosterone undecanoate injection for hypogonadism, due to concerns over side effects like anaphylaxis and pulmonary oil microembolism (POME). Despite the drug being approved in 94 other countries, the FDA's advisory committee was divided on its safety, leading to a third denial of approval. The FDA did not request further clinical studies but required an updated Risk Evaluation and Mitigation Strategy, including a medication guide and an Elements to Assure Safe Use plan. Some physicians, noting the rarity of reported side effects and the drug's international use, questioned the FDA's decision. The FDA's hesitance may also stem from concerns over the misuse of testosterone products. Endo Pharmaceuticals planned to respond to the FDA's feedback by the end of the third quarter of 2013.