FDA Declines Approval of Testosterone Drug for Third Time

In May 2013, the FDA rejected the approval of Aveed, a long-acting testosterone undecanoate injection by Endo Pharmaceuticals, for the third time due to concerns over severe side effects such as anaphylaxis and pulmonary oil microembolism (POME). This decision followed a split vote by an advisory committee in April, where nine members voted for approval and nine against. Aveed, designed to treat men with hypogonadism, offers a longer interval between treatments (every 10 weeks) compared to the 2–4 week interval required for other injectable testosterone replacement therapies already approved in the USA. Symptoms of hypogonadism include erectile dysfunction, infertility, reduced hair growth, and decreased muscle mass. Despite the availability of other testosterone replacement options like oral formulations, patches, gels, and tablets, Aveed's approval was declined due to safety concerns.