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FDA Approves Merck’s Zinplava (bezlotoxumab) to Reduce Recurrence of Clostridium difficile Infection

Posted 25 Oct 2016 by Drugs.com

KENILWORTH, N.J.--(BUSINESS WIRE) October 21, 2016 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Zinplava (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making Zinplava available in first quarter 2017. Zinplava is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. Zinplava is not indicated for the treatment of CDI. Zinplava is not an antibacterial drug. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI. CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI is higher in certain ... Read more

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Prevention of Clostridium Difficile Infection Recurrence

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Zinplava