Endo files response for Nebido application
USA-based Endo Pharmaceuticals' majority-owned subsidiary Indevus has filed with the Food and Drug Administration a complete response submission to the New Drug Application for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism.
Endo's chief executive, David Holveck, said: "we look forward to receiving the FDA's decision on the Nebido marketing application in September."
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