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FDA posts ceftaroline briefing documents

September 3, 2010 12:06 AM UTC

FDA said in briefing documents that data for ceftaroline from Forest Laboratories Inc. (NYSE:FRX) supports the product's efficacy in complicated skin and skin structure infections (cSSSIs) and community-acquired bacterial pneumonia (CABP). The documents come in front of Tuesday's Anti-Infective Drugs advisory committee meeting to discuss the compound.

FDA said ceftaroline was non-inferior to and showed a favorable trend over ceftriaxone on the primary endpoint of clinical cure rate in two Phase III trials for CABP. The documents also included an FDA sensitivity analysis that covered only subjects with confirmed baseline CABP pathogens, which the agency said supported the efficacy conclusions of the company's prespecified analyses. ...