FDA approves Endo International's testosterone drug

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FDA approves Endo International's testosterone drug

(Reuters) - Endo International Plc said the U.S. Food and Drug Administration approved its thrice-rejected testosterone replacement therapy, Aveed, to treat male hypogonadism. The regulator 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.

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