Cubist announced that the FDA has approved Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).

The approval of Sivextro was based on two Phase 3 studies that met both primary and secondary endpoints. The studies showed that Sivextro 200mg once daily for 6 days was non-inferior to linezolid 600mg twice daily for 10 days.

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Sivextro is a novel oxazolidinone antibacterial that binds to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis. Tedizolid inhibits bacterial protein synthesis through a mechanism of action different from that of other non-oxazolidinone class 13 antibacterial drugs; therefore, cross-resistance between tedizolid and other classes of antibacterial drugs is unlikely.

Sivextro will be available as 200mg strength tablets in 30-count bottles and 6-tablet blister packs, and as a 200mg single-dose vials in 10-count packages.

For more information call (844) CUBIST-CARES or visit Sivextro.com.