FDA approves CUBICIN 2-minute IV injection for MRSA skin infections, bacteremia

Dec 2 2010

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced 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. CUBICIN is the only approved 2-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated skin infections and bacteremia. In addition to 2-minute IV injection, several other changes to the CUBICIN label were incorporated. These include changes and reformatting of the Warnings and Precautions in the label, updates to the Post Marketing Experience section of the label, and re-formatting of the label to be compliant with the FDA's Physician Labeling Rule (PLR).

“We are pleased that doctors and healthcare providers will now have this option. Having to spend only 2 minutes a day receiving CUBICIN, especially for patients in the outpatient setting, minimizes the impact that IV therapy has on their daily activities.”

The FDA originally approved CUBICIN in 2003 as a once-a-day 30-minute infusion for the treatment of complicated skin and skin structure infections (cSSSI) caused by certain Gram-positive organisms. In 2006, the FDA granted further approval of CUBICIN for the treatment of Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis. To date, CUBICIN has experienced the most successful antibiotic launch in U.S. history, on a dollar sales basis. For full prescribing information, visit www.cubicin.com.

Cubist's President and CEO Michael W. Bonney said, "We are pleased that doctors and healthcare providers will now have this option. Having to spend only 2 minutes a day receiving CUBICIN, especially for patients in the outpatient setting, minimizes the impact that IV therapy has on their daily activities."