CDER Documents (secondary website for download at TMT's website)
Documents are listed in alphabetical order. When asked whether you want to Open, Save or Cancel, select Save.
Aleve OTC Naproxen Label - 2005-4090B1_04_C-Bayer-Hoffmann-Laroche-Appendix-2
Bextra Executive Summary - 2005-4090B1_01_Y-FDA-Tab-O
Bextra History - 2005-4090B1_01_X-FDA-Tab-N
Bextra Label - 2005-4090B1_01_Z-FDA-Tab-P-1
Bextra valdecoxib tablets - 2005-4090B1_01_AA-FDA-Tab-P-2
Bextra valdecoxib tablets Label - 2005-4090B1_01_BB-FDA-Tab-P-3
Bibliography Cox-2s - 2005-4090B1_01_HH-FDA-Tab-V-Bibliography
Briefing Package for Lumiracoxib - 2005-4090B1_01_GG-FDA-Tab-U
Cardiovascular Data in Vioxx Alzheimer's Studies Memo - 2005-4090B1_01_K-FDA-Tab-F-2
Celebrex 12-10-98 memo - 2005-4090B1_01_S-FDA-Tab-K-2
Celebrex Draft Label - 2005-4090B1_01_V-FDA-Tab-M-1
Celebrex Feb 2001 Briefing Package - 2005-4090B1_01_U-FDA-Tab-L-2
Celebrex History 2005-4090B1_01_Q-FDA-TAB-J
Celebrex Label - 2005-4090B1_01_W-FDA-Tab-M-2
Celebrex Medical Officer Review 7-8-98 - 2005-4090B1_01_R-FDA-Tab-K-1
Celebrex Medical Officer Review 9-20-00 - 2005-4090B1_01_T-FDA-Tab-L-1
Excerpts from Primary Vioxx Review - 2005-4090B1_01_F-FDA-Tab-D-1
FDA Response to Vioxx NDA - 2005-4090B1_01_M-FDA-Tab-H-1
Graham Sept 2004 memo on risk of MI and sudden death with Cox-2s 2005-4090B1_01_EE-FDA-Tab-S
Merck Briefing Document on Vioxx - 2005-4090B1_02_MERCK-Vioxx
Merck Etoricoxib Briefing Document - 2005-4090B2_01_Merck-Etoricoxib
Naprosyn - 2005-4090B1_01_DD-FDA-TAB-R
Naprosyn US Package Insert - 2005-4090B1_04_B-Bayer-Hoffmann-Laroche-Appendix-1
Novartis Lumiracoxib Briefing Document - 2005-4090B2_02_Novartis-Lumiracoxib
Overview 1-19-05 of Benefit-Risk - 2005-4090B1_01_B-FDA-TAB-A
Parecoxib Medical Officer Review - 2005-4090B1_01_CC-FDA-Tab-Q
PDF file of Cardiovascular Data in Vioxx Alzheimer's Studies Memo - 2005-4090B1_01_L-FDA-Tab-G
Proposed NSAID Package Insert Labelling Template - 2005-4090B1_01_D-FDA-TAB-B
Roche Briefing Book on Naproxen - 2005-4090B1_04_A-Bayer-Hoffmann-Laroche-Naprosyn
TARGET Summary Publications - 2005-4090B1_01_AC-FDA-Tab-V
Table of Contents 2-16-05 Sessions - 2005-4090B1_01_A-FDA-TOC
Vioxx 2000 Medical Officer Review - 2005-4090B1_01_H-FDA-Tab-E-1
Vioxx 2001 Medical Officer Review - 2005-4090B1_01_J-FDA-Tab-F-1
Vioxx CV Update Interim Data from APPROVe Study - 2005-4090B1_01_N-FDA-Tab-H-2
Vioxx History - 2005-4090B1_01_E-FDA-TAB-C
VioxxLabel - 2005-4090B1_01_O-FDA-Tab-I-1
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