Endo Pharmaceuticals and its majority-owned subsidiary Indevus Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for review the complete response submission to the new drug application for NEBIDO (testosterone undecanoate) 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.
The details can be read here.
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