March 06, 2014
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FDA approves injectable testosterone for hypogonadism

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Endo Pharmaceuticals announced today that the FDA has approved its testosterone undecanoate for hypogonadism, according to a company press release.

The approval comes after an 84-week phase 3 trial in the US in men diagnosed with hypogonaism, with an average age of 54 years and total serum testosterone levels less than 300 ng/dL. Data from the study demonstrated testosterone undecanoate (Aveed, Endo Pharmaceuticals) increased and maintained mean serum testosterone levels for up to 10 weeks.

The drug was approved with restricted distribution by prescription only and a Risk Evaluation and Mitigation System (REMS) which requires prescriber education and certification. Under a standard course of treatment, patients would receive a single 3-mL intramuscular injection, another at 4 weeks of treatment, followed by a single dose every 10 weeks thereafter.

Ana Fadich, MPH, vice president of Men’s Health Network, a national nonprofit organization, said, “Men’s Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options.”

The drug is expected to become available later this month.