Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence
Dateline City:
KENILWORTH, N.J.
FDA Grants Priority Review with Target Action Date of July 23, 2016
Marketing Authorization Application Also Filed with the European Medicines Agency
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA) for
bezlotoxumab, an investigational antitoxin for prevention of Clostridium
difficile (C. difficile) infection recurrence. The FDA
granted Priority Review for bezlotoxumab, with a Prescription Drug User
Fee Act (PDUFA) action date of July 23, 2016.
Language:
English
Contact:
MerckMedia:Pamela Eisele, 267-305-3558Robert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986Amy Klug, 908-740-1898
Ticker Slug:
Ticker: MRK Exchange: NYSE
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Source: Merck.com - Corporate News - Category: Pharmaceuticals Tags: Corporate News Latest News #Merck #MRK $MRK Bezlotoxumab ClostridiumDifficile NYSE:MRK Source Type: news