Pfizer parecoxib "not approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer's injectable COX-2 inhibitor parecoxib is "not approvable" a second time, the firm says Sept. 20. Pfizer plans to meet with FDA "as soon as possible" to discuss the agency's concerns. The company added that "it disagrees with the conclusions" stated in the letter. Parecoxib, the pro-drug of Pfizer's Bextra (valdecoxib), was first deemed not approvable in July 2001 (1Pharmaceutical Approvals Monthly December 2001, p. 26). Parecoxib is marketed outside the U.S. as Dynastat. Another Pfizer drug, the osteoporosis treatment Oporia (lasofoxifene), also was deemed not approvable recently; the company announced receipt of the latter letter Sept. 13...
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