FDA to discuss Cubist, Durata ABSSSI products

FDA's Anti-Infective Drugs Advisory Committee will meet on March 31 to discuss products from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) and Durata Therapeutics Inc. (NASDAQ:DRTX) to treat acute bacterial skin and skin structure infections (ABSSSI). The committee will discuss a pair of NDAs from Cubist covering the use of IV and oral formulations of tedizolid, a second generation oxazolidinone that inhibits bacterial protein biosynthesis. The PDUFA date for both applications is June 20. The committee also will discuss an NDA from Durata for IV dalbavancin ( RQ-00000002), which has a May 26 PDUFA date. The product is a second-generation once-weekly glycopeptide antibiotic. ...