March 12, 2009
FDA accepts complete response submission to NDA for NebidoEndo Pharmaceuticals and Indevus Pharmaceuticals have announced that the FDA has accepted for review their complete response submission to the New Drug Application (NDA) for Nebido (testosterone undecanoate). Nebido is an investigational intramuscular injection for the treatment of male hypogonadism. The FDA has targeted September 2, 2009 as the action date for a decision on this application.
For more information visit www.endo.com.