FDA approves Cubist's Sivextro

FDA approved an NDA for Sivextro tedizolid from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The approval covers IV and oral formulations of the second-generation oxazolidinone that inhibits bacterial protein biosynthesis. Cubist said it is finalizing launch plans, including pricing.

Sivextro has Qualified Infectious Disease Product (QIDP) designation from FDA for ABSSSI and hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP), for which it is in Phase III studies. The designations qualify Sivextro for an additional five years of market exclusivity. ...