Indevus Pharmaceuticals, Inc.

Indevus Receives Non-Approvable Letter From FDA for VALSTAR(TM)

Published in Health Business Week, January 4th, 2008

Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for VALSTAR(TM) related to its chemistry, manufacturing and controls (CMC) NDA supplement submitted to the FDA in May 2007. The letter was received following the Company's response to an August 2007 approvable letter.

The VALSTAR-specific issues that caused the 2002 withdrawal of the product from the market have been satisfactorily resolved. However, during a recent FDA pre-approval inspection of the Company's third-party manufacturing facility for VALSTAR, deficiencies were identified that require resolution prior to...

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Source: Health Business Week (2008-01-04)

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