Indevus Receives Non-Approvable Letter From FDA for Valstar

VALSTAR-specific Issues Have Been Resolved; Remaining Issues Pertain to cGMP Compliance of Third-party Manufacturing Facility

LEXINGTON, Mass., December 19, 2007 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. today 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 approval. The Company believes that successfully addressing the deficiencies at the manufacturing plant is the only remaining item for product approval. Upon resolution, which the Company expects to occur within several months, the Company will respond to the FDA and request re-inspection of the facility.

"We and our third-party manufacturer firmly believe we will be able to resolve the open cGMP issues within the next several months," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "We have been in direct communication with the FDA and they have committed to working closely with us and our manufacturer to resolve the open cGMP issues in an expeditious manner. They appreciate the need and desire to return VALSTAR, currently on the FDA Drug Shortages List, to the market as quickly as possible."

VALSTAR, a sterile solution of valrubicin for intravesical instillation, is the only product approved by the FDA for therapy of bacillus Calmette- Guerin (BCG)-refractory carcinoma in situ (CIS) of the urinary bladder. VALSTAR was removed from the market in 2002 due to impurities in the original formulation and was placed on the FDA Drug Shortages List. Indevus acquired VALSTAR through its acquisition of Valera Pharmaceuticals and after completing the resolution of the impurity issue, submitted a chemistry, manufacturing and controls (CMC) NDA supplement to the FDA in May 2007.