FDA approves tedizolid for ABSSSIs

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The FDA has approved tedizolid for the treatment of acute bacterial skin and skin structure infections, including those caused by MRSA.

Tedizolid (Sivextro, Cubist) is the second drug approved for ABSSSIs within the past month. Dalbavancin (Dalvance, Durata Therapeutics) was approved on May 23.

“Today’s approval provides physicians and patients with a new treatment option for serious skin infections,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.

Edward Cox

Tedizolid was evaluated in two clinical trials that included 1,315 adults with ABSSSI who were randomly assigned to tedizolid or linezolid. The results showed tedizolid was as effective as linezolid.

The application for tedizolid was designated as a qualified infectious disease product and received an expedited review.