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2008-09-19 | permalink
U.S. FDA assigns priority review to GTC Biotherapeutic’s ATryn
The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.’s Biologic License Application, or BLA, for ATryn. 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.
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2008-09-19 | permalink
U.S. FDA assigns priority review to GTC Biotherapeutic’s ATryn
The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.’s Biologic License Application, or BLA, for ATryn. 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.
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