FDA Approves Two-Minute IV for Superbug Skin Complications

Scanning electron micrograph image of MRSA bacteria (Janice Haney Carr, Centers for Disease Control and Prevention)

Cubist Pharmaceuticals Inc. in Lexington, Massachusetts says that its currently-marketed antibiotic Cubicin (daptomycin for injection) has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection. The company says Cubicin is the only approved 2-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated skin infections and bacteremia.

Cubist says it will also make several changes to the Cubicin label, including changes and reformatting of the Warnings and Precautions section, updates to the Post Marketing Experience section, and re-formatting of the label to be compliant with the FDA’s Physician Labeling Rule.

FDA originally approved Cubicin in 2003 as a once-a-day 30-minute infusion for the treatment of complicated skin and skin structure infections caused by certain Gram-positive organisms. In 2006, FDA granted further approval of Cubicin for the treatment of Staphylococcus aureus bacteremia.

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