Sivextro tedizolid phosphate regulatory update

FDA approved an NDA for Sivextro tedizolid from Cubist to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), various Streptococcus species and Enterococcus faecalis. 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). The designations qualify Sivextro for an additional 5 years of market exclusivity. ...