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FDA steps in over drugs manufacture


The stalling of key drugs due to manufacturing problems at a biotechnology company has prompted enforcement action by the US Food and Drug Administration.

Genzyme said it would have to make payments to the US government and the FDA was likely to require the inspection and review of plant operations by a third party for an extended period, although shipments of top-selling drugs Cerezyme and Fabrazyme are expected to continue.

Genzyme shut its manufacturing plant in Boston for about three months to clean up viral contamination that had been slowing down production of Cerezyme and Fabrazyme.

Then in November, the FDA said it found tiny particles of trash in drugs made by Genzyme, including steel, rubber and fibre. The agency recommended that doctors closely inspect vials of Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen.

Cerezyme treats Gaucher disease, while Fabrazyme treats an inherited disorder known as Fabry disease. Myozyme treats Pompe disease, which is a rare disorder that interferes with muscle development.

The company does not yet know the financial impact.

Copyright Press Association 2010
Department of Health

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