Regulatory Actions

Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients

Published in Healthcare Finance, Tax and Law Weekly, February 11th, 2009

Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on March 5, 2009 as required for a drug of a new therapeutic class.

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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Source: Healthcare Finance, Tax and Law Weekly (2009-02-11)

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