Endo Health Solutions Inc said the U.S. Food and Drug Administration approved its thrice-rejected testosterone drug, Aveed, to treat male hypogonadism.
The health regulator rejected the drug last May, saying that Endo needed a better plan to manage the risks associated with the drug.
Aveed, which contains testosterone and castor oil, is expected to be launched in early March, Endo said on Thursday.
Male hypogonadism is a condition characterized by low production of the hormone testosterone, often leading to a loss of libido, depression and fatigue.
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