GTC Biotherapeutics
FDA Assigns Priority Review to GTC Biotherapeutics' ATryn
Published in Medical Letter on the CDC and FDA, September 21st, 2008
The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.'s ("GTC", Nasdaq: GTCB) Biologic License Application, or BLA, for ATryn(R). Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA's target date for action on the BLA is February 7, 2009.
"We are pleased that the FDA has recognized the inherent advantage of ATryn(R) as the only recombinant antithrombin product that may become available to patients with hereditary...
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