The US Food and Drug Administration (FDA) approved Orbactiv (oritavancin), a new antibacterial drug to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis.

Orbactiv is administered intravenously. It is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The FDA approved Dalvance (dalbavancin) in May 2014 and Sivextro (tedizolid) in June 2014. All three were designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Orbactiv was given priority review and granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection. Orbactiv’s QIDP designation also qualifies it for an additional 5 years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act.

In two clinical trials comprising 1,987 adults with ABSSSI, those participants who received Orbactiv did as well as their counterparts who were randomized to receive vancomycin. The most common side effects were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea.

Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.

Orbactiv is marketed by The Medicines Company, based in Parsippany, NJ.