Food and Drug Administration

Joint Meeting With the

Arthritis Advisory Committee

and the

Drug Safety and Risk Management Advisory Committee

February 16-18, 2005

Briefing Information

Food and Drug Administration

Briefing Information (HTM)

Merck Research Laboratories

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

VIOXX™ (Rofecoxib Tablets and Oral Suspension) - Background Information (PDF)

ARCOXIA™ (Etoricoxib Tablets) - Background Information (PDF)

Pfizer, Inc.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Celecoxib and Valdecoxib Cardiovascular Safety - Background Information (PDF)

Hoffmann-La Roche, Inc. and Bayer Healthcare LLC

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Naproxen - Background Information (PDF)

Appendix 1 - USPI For Naproxen (PDF)

Appendix 2 - Label for OTC Naproxen (PDF)

Novartis Pharmaceutical Corporation

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Lumiracoxib (COX189) - Background Information (HTM) (PDF) (Word)

Errata (HTM) (PDF) (Word)