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FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
Date:11/1/2007

LEXINGTON, Mass., Nov. 1 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for NEBIDO(R), its long-acting injectable testosterone preparation for the treatment of male hypogonadism. The FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO is June 27, 2008. The NDA was submitted to the FDA by the Company on August 28, 2007.

The NDA contains data from six clinical studies in which over 400 patients received at least one dose of NEBIDO, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of NEBIDO have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO.

About NEBIDO

NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. NEBIDO is expected to be the first three-month testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk o
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SOURCE Indevus Pharmaceuticals, Inc.
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