ARTICLE | Company News

Genzyme meets first consent decree deadlines

November 24, 2010 11:00 PM UTC

Genzyme Corp. (NASDAQ:GENZ) met FDA's deadlines this week to move fill/finish operations for two U.S. products out of the company's Allston, Mass., manufacturing facility. Genzyme's manufacturing third party Hospira Inc. (NYSE:HSP) now conducts fill/finish activities for thyroid cancer adjunct Thyrogen thyrotropin alfa and Fabry's disease drug Fabrazyme agalsidase beta. The move also allows Genzyme to resume full U.S. marketing and distribution activities for Thyrogen, which had been restricted under FDA's consent decree regarding deficiencies at the plant. Missing the deadlines would have imposed a penalty of 18.5% of revenues from those products. ...