The FINANCIAL -- Sanofi and its subsidiary Genzyme announced that the Food and Drug Administration has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme, according to Sanofi.

This follows the previously announced approval by the European Medicines Agency last week.Approval of the Framingham site allows Genzyme to begin the process of returning patients to full dosing levels. Following the EMA approval, Genzyme will begin the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in Q1 2012.

Beginning in March, all patients in the U.S. currently on therapy will be returned to full dosing. In addition, the company will begin to transition new patients in the U.S. onto Fabrazyme, at full dosing levels.

Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.

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