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FDA advisory panel recommends approval of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
Tuesday, September 07 2010 | Comments
What's This?
A Food and Drug Administration advisory committee unanimously supported Cerexa Inc.'s ceftaroline fosamil, an investigational antibiotic, as a treatment for community-acquired bacterial pneumonia (CABP) and complicated skin and skin structure infections (cSSSIs).The agency's Anti-Infective Drugs Advisory Committee voted 21-0 in favor of the CABP indication and 18-0 in favor of the cSSSI indication.
Cerexa, a subsidiary of Forest Laboratories Inc., submitted a New Drug Application covering the two indications in December. The filing included data from two Phase III CABP trials that compared ceftaroline with ceftriaxone sodium in adults requiring IV antimicrobial therapy in an acute care setting and two Phase III cSSSI trials that compared the agent with vancomycin hydrochloride plus aztreonam in adults also requiring treatment in an acute care setting.
Forest said it expects the FDA to make a decision on the antibiotic, a broad-spectrum, intravenous, next-generation cephalosporin, during the fourth quarter.
According to Thomson Reuters forecasts, the antimicrobial is projected to attain approximately $360 million in sales in 2014 if the FDA approves it, Reuters reported.
Forest obtained the rights to ceftaroline in countries other than Japan when it acquired Cerexa in 2006.
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