The FDA has approved Aveed (testosterone undecanoate injection; Endo Pharmaceuticals) for the treatment of hypogonadism in adult men. Aveed is indicated as a testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in adult males.

The approval was based on data from a Phase 3 trial of hypogonadal men over 84 weeks. The average patient age was 54 years with a serum total testosterone level of less than 300ng/dL. Aveed was shown to increase mean serum testosterone levels, while maintaining them for up to 10 weeks at a stable level (between weeks 14–24).

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Aveed is only available through the restricted Aveed Risk Evaluation and Mitigation Strategy (REMS) Program. Expected availability is in early March.

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