MTFB Motif Bio PDUFA Iclaprim

When:
February 13, 2019 all-day
2019-02-13T00:00:00-05:00
2019-02-14T00:00:00-05:00

On Aug. 14, 2018 Motif Bio plc $MTFB, a clinical-stage biopharmaceutical company specializing in developing novel antibiotics announced that the FDA had accepted their filing of the New Drug Application (NDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The NDA has been granted Priority Review, and the FDA has set a target decision date under the Prescription Drug User Fee Act (PDUFA) of February 13, 2019.

MOTIF BIO ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION WITH PRIORITY REVIEW FOR ICLAPRIM FOR TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS

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