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Merck: FDA To Review Two Applications For DIFICID - Quick Facts

Merck (MRK) announced the U.S. FDA has accepted for review a New Drug Application for DIFICID (fidaxomicin) for oral suspension, and a supplemental NDA, or sNDA, for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium difficile infections in children aged six months or older. The sNDA is based primarily on results of the Phase 3 SUNSHINE study.

Merck said the applications have received a priority review classification by the FDA. The target action date for the applications, is set for Jan. 24, 2020.

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