Posted by Michael Wonder on 27 Jan 2020
FDA approves Merck’s Dificid (fidaxomicin) to treat Clostridioides difficile in children aged six months and older
27 January 2020 - Merck today announced the U.S. FDA has approved a new drug application for Dificid (fidaxomicin) for oral suspension, and a supplemental new drug application for Dificid tablets for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhoea in children aged six months and older.
Both applications received a priority review classification by the FDA. The investigational paediatric indication for Dificid was granted orphan drug designation in 2010.
