Arthritis
FDA Advisory Committee Recommends Against Approval for Merck's NDA for ARCOXIA (etoricoxib)
Published in Medicine and Law Weekly, May 4th, 2007
Merck & Co., Inc. announced that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee voted against recommending approval at this time of ARCOXIA(R) (etoricoxib) for the symptomatic treatment of osteoarthritis in the United States. ARCOXIA has been under review by the FDA as an investigational selective COX-2 inhibitor since the New Drug Application (NDA) was submitted in December 2003 and is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa.
"We are disappointed in today's outcome. We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many...
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