The drug is sanctioned to treat methicillin-resistant Staphylococcus aureus (MRSA) and other acute bacterial skin infections. It's the third such drug approved in 2014, following May approval of Dalvance (dalbavancin) and June approval of Sivextro (tedizolid), the FDA said.
Orbactiv's safety and effectiveness were evaluated in two clinical studies involving almost 2,000 adults. The most common side effects included headache, nausea, vomiting, skin abscesses on the arms and legs, and diarrhea.
The drug's label will include a boxed warning that it could interact with the blood-thinning medication warfarin, the agency said.
Orbactiv is marketed by The Medicines Company, based in Parsippany, N.J.
The FDA has more about this approval.
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