The newly approved treatment is an intravenously administered drug treating ABSSSI infections caused by susceptible bacteria such as Staphylococcus aureus, MRSA, Streptococcus species and Enterococcus faecalis, according to a news release.
This is the third antibacterial drug the FDA has approved this year to treat ABSSSI. Dalvance (dalbavancin) was approved in May and Sivextro (tedizolid) was approved in June, according to the news release.
Orbactiv was designated as a Qualified Infectious Disease Product due to its intention to treat serious or life-threatening infection. Due to its designation, the drug was given priority review, including an expedited review of its application.
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