FDA Rejects Endo Testosterone Drug For 3rd Time

Law360, Washington (May 31, 2013, 4:55 PM EDT) -- The U.S. Food and Drug Administration has again refused to approve Endo Health Solutions Inc.'s testosterone replacement injection Aveed and has requested additional risk information before considering the drug a fourth time, the company said Thursday.

Although Endo noted FDA did not ask the company to undergo additional clinical studies for the hypogonadism treatment, the agency requested updates to Endo's risk evaluation and mitigation strategy to ensure the drug is used properly.

In particular, Endo said FDA asked for a medication guide and additional instructions that...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.