FDA panel unanimously backs ABSSSI products
FDA's Anti-Infective Drugs Advisory Committee voted unanimously in favor of approval of Sivextro tedizolid from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) and Dalvance dalbavancin ( RQ-00000002) from Durata Therapeutics Inc. (NASDAQ:DRTX) to treat acute bacterial skin and skin structure infections (ABSSSI). Cubist is seeking approval of IV and oral formulations of Sivextro, a second-generation oxazolidinone that inhibits bacterial protein biosynthesis. The PDUFA date is June 20. Durata is seeking approval of an IV formulation of Dalvance, a second-generation glycopeptide antibiotic. The PDUFA date is May 26. Both dalbavancin and tedizolid are under Priority Review and have Qualified Infectious Disease Product (QIDP) designation from FDA for ABSSSI. ...