Aveed is FDA approved for Testosterone Deficiency- Endo Pharma

Endo International plc announced that its operating company Endo Pharmaceuticals Inc. received FDA approval on 5 March 2014 of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Aveed is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

The approval of Aveed is based on data from an 84-week Phase III trial of hypogonadal men in the U.S. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. In the Phase III study, Aveed increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14-24). Aveed is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.

The FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.