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Prexige “not approvable”

Executive Summary

Novartis receives a "not approvable" letter from FDA for its COX-2 inhibitor lumiracoxib for osteoarthritic pain, firm announces Sept. 27. The negative outcome is not unexpected as CEO Daniel Vasella previously told analysts, "I don't think we will get an approval" (1"The Pink Sheet" Sept. 17, 2007, p. 11). Novartis is not completely abandoning hope that Prexige could be approved for specific populations, such as patients with a higher incidence of gastrointestinal complications, including those suffering from ulcers or being treated with anticoagulants...

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