ARTICLE | Regulation

Complicated but uncontroversial

Forest's Ceftaroline clears higher FDA hurdles for pneumonia, skin infections

September 13, 2010 7:00 AM UTC

Last week's FDA panel meeting to discuss ceftaroline from Forest Laboratories Inc. was devoid of the controversy that has surrounded reviews of other antibiotics to treat either community-acquired bacterial pneumonia or complicated skin and skin structure infections.

The keys to the compound's ability to sail through the Anti-Infectives Drugs Advisory Committee were the same for both indications. Most importantly, the compound clearly works: it not only met the prespecified endpoints of the company's studies, but also held up to FDA's post hoc analyses, which were based on guidances issued after the trials had been designed...