FDA accepts Merck’s two applications for Dificid

The FDA accepts for review Merck’s (NYSE:MRK) 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 in children aged six months or older.

Under Priority Review Status, the agency’s action date is January 24, 2020, for both the applications.

https://seekingalpha.com/news/3503248-fda-accepts-mercks-two-applications-dificid