FDA Approves Aveed Injection For Men With Hypogonadism

Endo International Plc March 6 said that its operating company, Endo Pharmaceuticals Inc., received approval from the Food and Drug Administration for Aveed (testosterone undecanoate) injection.

Aveed treats adult men with hypogonadism associated with a deficiency or absence of the male hormone testosterone, the Ireland-based company said.

Aveed is approved with a risk evaluation and mitigation strategy (REMS) requiring prescriber education and certification, as well as restricted product distribution, Endo said.

The company said it expects Aveed to be available in the U.S. in early March.

In April 2013, an FDA advisory panel had mixed views on whether the agency ...