VALSTAR-specific Issues Have Been Resolved; Remaining Issues Pertain to
cGMP Compliance of Third-party Manufacturing Facility
Company Expects to Resolve cGMP Issues in the Next Several Months
LEXINGTON, Mass., Dec. 19 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) 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 ma
|SOURCE Indevus Pharmaceuticals, Inc.|
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