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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.
Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use.
Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved Dalvance (dalbavancin), also to treat patients with ABSSSI caused by Staphylococcus aureus and various Streptococcus species.
For more information, please visit: Sivextro.
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