Regulatory Actions
Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
Published in Medical Letter on the CDC and FDA, February 15th, 2009
Savient submitted its BLA to the FDA on October 31, 2008 seeking approval to market pegloticase in the United States. On December 29, 2008, the FDA accepted the BLA filing for review and granted priority review. A priority review is an FDA designation that is assigned to products that if approved, would provide a significant improvement in the safety or...
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