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U.S. FDA panel deadlocked over Endo's testosterone drug
April 18, 2013 / 7:41 PM / 4 years ago

U.S. FDA panel deadlocked over Endo's testosterone drug

April 18 (Reuters) - An advisory panel to the U.S. Food and Drug Administration was deadlocked over whether the agency should approve Endo Health Solutions Inc’s experimental drug to treat low testosterone in men.

The panel on Thursday voted 9-9 on whether the drug is safe for the treatment of conditions associated with low testosterone. It voted 17-1 that the company’s proposed instructions to doctors for mitigating potential risks were insufficient.

Analysts were not expecting the drug, Aveed, to be warmly reviewed by the panel based on the negative tone of an FDA staff review of the drug that was posted on the agency’s website on Tuesday.

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