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FDA finds the injectable COX-2 inhibitor parecoxib "not approvable," Pfizer says Sept. 20. The company plans to meet with FDA "as soon as possible" to discuss the future of the application and says it "disagrees with the conclusions" made by FDA in the letter. FDA previously found parecoxib not approvable in 2001; that review raised questions about the product's efficacy and safety (1"The Pink Sheet" Feb. 14, 2005, p. 11)...
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