Protalix BioTherapeutics has submitted its reply to the Complete Response to the FDA after its review of its New Drug Application for taliglucerase alfa (PLX) 6.44 : Co announced today that it has submitted its reply to the Complete Response Letter issued in February 2011 by the U.S. Food and Drug Administration (FDA) after its review of the Company's New Drug Application (NDA) for taliglucerase alfa. Taliglucerase alfa, the Company's proprietary plant-cell expressed form of glucocerebrosidase (GCD), is in development for the treatment of Gaucher disease. "We believe we have adequately addressed the requests that were outlined by the FDA in their Complete Response Letter," said Dr. David Aviezer, President and CEO of Protalix. "We will continue to work closely with the FDA as it moves forward with the NDA review." On November 30, 2009, Pfizer and Protalix BioTherapeutics, Inc. entered into an agreement to develop and commercialize taliglucerase alfa. The Company expects the FDA to provide an updated Prescription Drug User Fee Act (PDUFA) target action date within weeks, which is consistent with FDA guidelines.
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