Sivextro tedizolid phosphate regulatory update

EMA’s CHMP recommended approval of oral and IV Sivextro tedizolid from Merck to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. CHMP said the authorization would include a pharmacovigilance plan. FDA approved the second-generation oxazolidinone that inhibits bacterial protein biosynthesis last June to treat ABSSSI caused by susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) (see BioCentury, June 30, 2014). ...