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07 March 2014

FDA approves new testosterone drug

The FDA has approved testosterone undecanoate injection for the treatment of adult men with hypogonadism associated with a deficiency or absence of the male hormone testosterone.

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Endo International Plc said the US Food and Drug Administration has approved testosterone undecanoate (Aveed) injection for the treatment of adult men with hypogonadism that is associated with a deficiency or absence of the male hormone testosterone.

Aveed is "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," the company said in a statement. The drug is expected to be available in early March.

Concerns about castor oil

Aveed is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution. The FDA rejected the treatment last May, saying that the company needed a better plan to manage risks associated with the long-acting drug that contains testosterone and castor oil. The FDA had expressed concerns about the risk of the castor oil in the formulation causing blockages in blood vessels in the lungs and of complications linked to post-injection reactions.

In February, a consumer advocacy group urged the FDA to delay its decision on Aveed, saying drugs treating low testosterone should carry strong warnings about the risk of heart problems. Testosterone treatments currently include skin patches, short-acting injections and topical gels. AbbVie Inc's AndroGel, the market leader, generated about $1.2 billion in sales in 2012.

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