FDA accepts two applications for Dificid to treat children aged six months up to 18 years with Clostridium difficile infections.- Merck Inc.
Merck Inc.,has announced the FDA has accepted for review a New Drug Application (NDA) for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA (sNDA) for a new indication for use of Dificid tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides) difficile infections (CDI) in children aged six months or older. Both applications have received a priority review classification by the FDA. The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for 24 January 2020.
The investigational pediatric indication for Dificid was granted Orphan Drug Designation (ODD) in 2010.
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