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Merck’s Dificid Approved for Clostridioides Difficile in Children

February 3, 2020

The FDA approved Merck’s NDA for Dificid (fidaxomicin) for oral suspension, and its supplemental NDA (sNDA) for Dificid tablets for treating clostridioides difficile-associated diarrhea (CDAD) in children six months and older.

The antibacterial product is indicated in adults and pediatric patients six and older for treating CDAD, a bacterial infection that usually occurs when a patient has been taking antibiotics. Both approved applications received priority review from the FDA.

The agency approved the adult indication of the drug in 2011 and granted Dificid orphan drug status for its pediatric indication in 2010.

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