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Forest's Ceftaroline Data Robust Even Under New Antibiotic Efficacy Standards, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Sensitivity analyses provide a way around proposed changes in FDA's data requirements for skin infections and community-acquired bacterial pneumonia.

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Forest's Unlikely Co-Sponsor For Ceftaroline Review: FDA Steps In

FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data. Reprinted from The RPM Report, November 2010.

Forest's Unlikely Co-Sponsor For Ceftaroline Review: FDA Steps In

FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data. Reprinted from The RPM Report, November 2010.

Forest Must Resolve Breakpoint Issues On Road To Ceftaroline Approval

Negotiation of breakpoints appears to be the final hurdle as Forest Laboratories seeks approval for ceftaroline fosamil to treat serious skin infections and community-acquired bacterial pneumonia.

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