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Indevus and FDA Agree on Path Forward for NEBIDO(R)
Date:9/26/2008

l trials prior to resubmission or approval," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "FDA also agreed with our outline of the proposed risk mitigation plans that included appropriate labeling description of intramuscular injection technique, adequate labeling information regarding allergic and oil-based reactions, and the commitment to conduct a large, simple post-marketing study. Risk mitigation plans are now commonly added to approval of new drugs and our agreed plans are consistent with FDA's new initiatives for the management of safety of new drugs. Given a six month FDA review time, assuming approval, we will be in a position to launch NEBIDO with our sales force in the fourth quarter of calendar 2009. We remain enthusiastic about the marketplace opportunity for a long-acting injectable testosterone therapy and we expect the introduction of NEBIDO to have a significant positive impact on the Company's business plan."

About NEBIDO(R)

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

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development, and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. T
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SOURCE Indevus Pharmaceuticals, Inc.
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