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