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FDA accepts Motif Bio's NDA with priority review for Iclaprim
Discussion: FDA accepted for filing the NDA of Motif Bio’s (MTFB) iclaprim. Iclaprim is a gram-positive investigational antibiotic, targeted for the treatment of acute bacterial skin and skin structure infections (‘ABSSSIs). The application will be treated under priority review and now has a target PDUFA on February 19, 2019. Earlier, FDA granted Qualified Infectious Disease Product designation and fast track status to the drug. NDA for the candidate was submitted in June 2018.
Motif Bio reported top-line