Materials for FDA's Cox-2 Safety Advisory Meeting Posted

The FDA has posted briefing information on its Feb. 16-18 joint advisory committee meeting to examine risk-benefit considerations for Cox-2 selective nonsteroidal anti-inflammatory drugs and related agents.

The joint meeting of the FDA's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee will include presentations from the FDA, Merck, Pfizer, Hoffmann-La Roche and Bayer Healthcare and Novartis Pharmaceuticals.

In addition to research and labeling information for the Cox-2 inhibitors that are currently on the market, the background data includes analyses of Merck's Arcoxia (etoricoxib) and Novartis' Prexige (lumiracoxib), two Cox-2 drugs that have yet to receive FDA approval.

To access the background materials for the Feb. 16 session, go to http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090b1.htm (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090b1.htm). To view the materials for the Feb. 17 session, go to http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090b2.htm (http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090b2.htm).