Endo Pharmaceuticals (ENDP) and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. (IDEV) said that the U.S. Food and Drug Administration has accepted for review the complete response submission to the new drug application for NEBIDO intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism.
FDA is targeting September 2, 2009 as the action date for a decision on this application.
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