The FDA voted not to approve Merck’s NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along with review of a separate related NDA for a 30 mg once-daily dose submitted in April 2004. The FDA’s letter indicated that Merck would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of th...