Cubist Gets FDA Go-Ahead for Two-Minute IV Injection of Antibiotic
Label changes were also made to Cubicin.
FDA has approved Cubist Pharmaceuticals’ marketed antibiotic, Cubicin®, for once-a-day dosing as a two-minute intravenous (IV) injection. Several other changes were also made to the Cubicin label.
Cubist notes that amendments include changes and reformatting of the Warnings and Precautions in the label, updates to the Post Marketing Experience section of the label, and reformatting of the label to be compliant with the FDA’s Physician Labeling Rule.
Cubicin is now the only approved two-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated skin infections and bacteremia, according to the company. FDA originally sanctioned 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, the agency granted further approval for the treatment of Staphylococcus aureus bacteremia including those with right-sided infective endocarditis. Cubicin is also available outside the U.S. for the same or similar indications.
During this year’s third quarter, Cubicin net sales in the U.S. increased 12% over last year’s third quarter to $154.5 million. Cubist’s net product revenues from international sales in the third quarter of 2010 were $6.0 million, an increase of 53% over the third quarter of 2009.
Sales in the U.S. during 2009 increased 26% over 2008 to $524.0 million. The company’s share of full-year 2009 international net product revenues was $13.8 million, which represents an increase of $6.4 million from full-year 2008 international product revenues.