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NDA, sNDA for C. diff drug fidaxomicin accepted for review by FDA

Merck's new drug application for its oral suspension form of fidaxomicin, indicated for the treatment of Clostridium difficile infections, has been accepted by the FDA for review, as well as a supplemental NDA for fidaxomicin in oral suspension and tablet forms to treat children six months of age and older. The sNDA is backed by data from its late-stage SUNSHINE study that compared the clinical response of 148 pediatric patients with C. difficile-related diarrhea after being administered fidaxomicin via oral suspension or tablets versus vancomycin capsules or oral liquid.

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