FDA Staff Has Concerns Over Endo Testosterone Replacement

Law360, New York (April 16, 2013, 7:03 PM EDT) -- An application for a new testosterone replacement drug by Endo Pharmaceuticals has serious safety risks that may outweigh its benefits, according to a report by U.S. Food and Drug Administration reviewers released Tuesday ahead of an advisory committee meeting on the new drug application.

Endo's testosterone replacement therapy Aveed, an intramuscular injection, has been rejected by the FDA twice so far, in 2008 and 2009, over similar safety issues.

At issue is the risk of severe adverse reactions after injection. Patients could experience a  potentially fatal...
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