FDA to Rule on Genzyme Drug in Six Months

1/21/10

The FDA has told Cambridge, MA-based Genzyme (NASDAQ:GENZ) that the agency plans to make a decision on its application for approval of Pompe drug alglucosidase alfa (Lumizyme) made in 4,000-liter batches by June 17, according to the company. The agency decided not to approve the treatment in November, citing lingering issues at Genzyme’s Allston Landing plant in Boston, where the drug is no longer manufactured. Genzyme plans to manufacture the treatment—which is marketed outside the U.S. as Myozyme—at its facility in Geel, Belgium.

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