FDA announces approval for Orbactiv

SILVER SPRING, Md. — The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections. The drug is administered intravenously.



Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The agency previously announced approval for Dalvance and Sivextro.



“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”



Orbactiv is marketed by the Medicines Co.