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See Latest ArticlesGenzyme Submits All Information Requested by FDA for Lumizyme
Genzyme, 05/22/09
Genzyme Corporation announced that it has submitted the final documentation to address all items in the FDA's complete response letter for Lumizyme, produced at the 2,000 L bioreactor scale. The submission included clinical data requested by the FDA from Genzyme's Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy and the final label for the product.
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