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Merck Statement on FDA Advisory Committee Meeting for ZINPLAVA (bezlotoxumab), an Investigational Agent for Prevention of Clostridium difficile Infection Recurrence
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“We believe that ZINPLAVA has the potential to offer physicians an important new therapy for their patients to help prevent C. difficile infection recurrence,” said Dr. Nicholas Kartsonis, associate vice president, infectious disease clinical research, Merck Research Laboratories. “We look forward to continuing to work with the FDA as it completes its review of our Biologics License Application for ZINPLAVA.”The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing investigational medicines. The Prescription Drug User Fee Act (PDUFA) action date for the FDA’s review of ZINPLAVA is July 23, 2016.
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Related Keywords Bezlotoxumab, Zinplava, Clostridium Difficile, Infection Recurrence