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Genzyme Myozyme revised PDUFA date

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genzyme's Pompe disease treatment Myozyme (alglucosidase alfa) has a revised user fee date of April 28 following FDA's 90-day extension. The extension is to provide time to review additional agency-requested information, Genzyme says. The company submitted the BLA July 28 (1Pharmaceutical Approvals Monthly August 2005, In Brief); the enzyme replacement therapy is receiving a priority review...

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