What information did the FDA review to arrive at its decisions?
The FDA’s Center for Drug Evaluation and Research (CDER) considered the risk/benefit profile for each of the drugs Cox-2 selective drugs, and the cardio-vascular risks of NSAIDs as a class. We reviewed the regulatory histories and NDA databases of the various NSAIDs, FDA and sponsor background documents prepared for the joint Advisory Committee meeting, all materials and data submitted by other stakeholders to the Advisory Committee meeting, presentations made at the joint meeting, the discussions held by the Committee members during the meeting, and the specific votes and recommendations of the joint Committee.
