Monday, July 21, 2008

CSL Behring Submits BLA Requesting Approval of Human Fibrinogen

KING OF PRUSSIA, Pa., July 21 /PRNewswire/ -- CSL Behring announced today that it has submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA)requesting approval to market its human fibrinogen concentrate in the United States for the treatment of congenital fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of fibrinogen.
"Submission of the BLA for human fibrinogen concentrate reinforces CSL Behring's commitment to developing and providing effective therapies for patients who suffer from coagulation disorders," said Robert Lefebvre, Vice President and General Manager of U.S. Commercial Operations at CSL Behring.
"We look forward to making this new therapy available in the U.S. upon FDA approval, and fulfilling a significant unmet medical need for patients with congenital fibrinogen deficiency."

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