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FDA Approves New Single-Dose Antibiotic for Serious Skin Infections — Physician’s First Watch

Medical News |
August 8, 2014

FDA Approves New Single-Dose Antibiotic for Serious Skin Infections

By Kristin J. Kelley

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

The FDA has approved a new single-dose treatment for adults with acute bacterial skin and skin structure infections that are caused by susceptible Gram-positive bacteria such as Staphylococcus aureus. Oritavancin, marketed as Orbactiv, is administered intravenously and can be given in an outpatient setting.

Oritavancin was as effective as vancomycin in two randomized trials of nearly 2000 patients. The drug's label will warn of interaction with the anticoagulant warfarin and interference with coagulation tests. Common side effects included diarrhea, headache, nausea, vomiting, and skin and soft tissue abscesses on the arms and legs.

This is the third antibacterial approved this year for treating skin and soft tissue infections. Dalbavancin and tedizolid were approved in May and June, respectively.

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