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Pfizer lasofoxifene review extension

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA extends its June 19 action date by three months for Pfizer's selective estrogen receptor modulator Oporia (lasofoxifene) for treatment of osteoporosis, Pfizer says July 20. Pfizer was "so thorough and provided so much data [in response to the agency's questions] that the FDA decided that this…constituted a new review cycle," Global R&D President John LaMattina told investors. Pfizer previously suggested that Oporia could have advantages over Lilly's market leading SERM Evista (raloxifene), reflected in parameters for bone resorption, bone mineral density and LDL cholesterol reduction (1Pharmaceutical Approvals Monthly October 2004, p. 25)...

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