Regulatory Actions
Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
Published in Medical Letter on the CDC and FDA, February 10th, 2008
Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) announced additional positive results from its Phase III program for NEBIDO (testosterone undecanoate), a long-acting injectable testosterone therapy under development for the treatment of male hypogonadism. The trial data announced has been filed with the U.S. Food and Drug Administration (FDA) as an addition to data contained in the Company's existing New Drug Application (NDA) that was originally filed on August 28, 2007. Based on recent conversations with the FDA, the Company anticipates that the FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO will remain June 27, 2008.
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