Genzyme progresses on FDA consent decree
Genzyme Corporation (NASDAQ: GENZ) announced today that the company has ended fill/finish operations within its Allston plant for products sold in the United States, as required by the FDA consent decree. All fill/finish activities for Cerezyme® (imiglucerase for injection), Myozyme® (alglucosidase alfa), Fabrazyme® (agalsidase beta) and Thyrogen® (thyrotropin alfa for injection) for the U.S. market now take place at Genzyme’s Waterford, Ireland plant, and at an external contract manufacturer. With this move, all previous restrictions on the marketing and distribution of Thyrogen within the United States have been lifted.
All remaining fill/finish activities in Allston for products sold outside of the United States must be ended by August 31, 2011. Genzyme is working closely with regulatory authorities globally to achieve this goal.
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