Food and Drug Administration
Joint Meeting With theand the
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)