Posted by Michael Wonder on 02 Oct 2019
FDA accepts two applications for Merck’s Dificid (fidaxomicin) to treat children aged six months up to 18 years with Clostridium difficile infections
2 October 2019 - Dificid paediatric filings receive priority review classification.
Merck today announced the U.S. FDA has accepted for review a new drug application for Dificid (fidaxomicin) for oral suspension, and a supplemental new drug application 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.
Both applications have received a priority review classification by the FDA.
The Prescription Drug User Fee Act, or target action date for both applications, is set for 24 January 2020.
The investigational paediatric indication for Dificid was granted orphan drug designation in 2010.
