Cubist Pharma: FDA Accepts NDA For Its Tedizolid, TR-701, With Priority Review

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) announced the U.S. FDA has accepted the company's New Drug Application for its investigational antibiotic tedizolid phosphate (TR-701) with priority review. The FDA has assigned a PDUFA action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections, or ABSSSI.

The company said its NDA submission is based on positive data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency.