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FDA Advisory Committee Votes Down Merck’s Arcoxia NDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck’s Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the 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. Merck presented data from a comprehensive clinical program that included effica...

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