OVATION Pharmaceuticals, Inc.
ATryn antithrombin alfa BLA Filing Accepted by FDA
Published in Medical Letter on the CDC and FDA, October 26th, 2008
OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ATryn(R) (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC Biotherapeutics, allowing the company to develop and commercialize the product in this country. The acceptance of the BLA comes just one month after the FDA assigned a priority review to the product, which has also been granted orphan drug designation. An action letter is expected in February, 2009.
ATryn is under review for the treatment of a rare disorder called hereditary antithrombin deficiency, or HD, involving...
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