Update on Remaining Two Lots of Cerezyme (8/25/09)
On August 10, Genzyme announced that we were in discussions with regulatory authorities regarding the remaining two lots of Cerezyme that were finished before the Allston plant was shut down. After discussions with FDA, Genzyme has moved forward with the final quality control and assurance measures taken prior to release of product to market in the U.S. One of the two lots has completed this process and has been released, and the other lot is midstream through this release process. Genzyme is in continued discussions with other regulatory agencies, including EMEA, and we anticipate updating the community again in the near future on the status of this Cerezyme material.