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Motif Bio submits application for antibiotic medicine with US FDA

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Motif Bio submits application for antibiotic medicine with US FDA

Motif Bio PLC submitted an application with the U.S. Food & Drug Administration, seeking approval to market its investigational antibiotic for treating bacterial skin infections.

The New York-based biopharmaceutical company said it submitted a new drug application with the U.S. regulator for iclaprim, which was evaluated in two successful phase 3 trials.

Iclaprim is expected to receive priority review, meaning the U.S. FDA will make a decision on the medicine within six months instead of the standard 10-month review period.

The drug may also be eligible for 10 years of market exclusivity in the U.S.