CEFTAROLINE ADVISORY COMMITTEE MEETING

The FDA Anti-Infective Advisory Committee will meet on Sept 7, 2010 to discuss the NDA for ceftaroline.  The FDA released it’s briefing document and questions before the long Labor Day weekend, perhaps to give the sponsor the opportunity to relax a little before the Tuesday meeting.  Relax they should because the FDA reviewers appear to have few if any issues regarding the safety or efficacy of the drug.  The questions to the Advisory Committee members from the FDA could not be more basic.  We think this one should get a positive nod from the committee.