FDA Approves Another Drug for Treating Acute Infections

Orbactiv is approved for treating patients with MRSA and some other bacteria.

The U.S. Food and Drug Administration approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with acute bacterial skin infections, including Staphylococcus aureus (both methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis, on Aug. 6. The drug is administered intravenously. It is marketed by The Medicines Company, based in Parsippany, N.J.

Orbactiv is the third new antibacterial drug FDA has approved this year to treat such infections; the others are Dalvance (dalbavancin) and Sivextro (tedizolid). "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 Dr. Edward Cox, M.D., MPH, director of the Office of Antimicrobial Products in 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 also is the third new drug designated as a Qualified Infectious Disease Product to receive FDA approval. Under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act, Orbactiv was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.

According to FDA's news release, the most common side effects identified in clinical trials of the drug were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea. Orbactiv's label includes a warning about interference with coagulation tests and interaction with warfarin, a drug that is used to prevent blood clots.

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