Bazedoxifene

Bazedoxifene is a selective estrogen receptor modulator (SERM), developed by Wyeth Pharmaceuticals, undergoing clinical evaluation for the prevention and treatment of postmenopausal osteoporosis. It is currently in the early phases of review by the United States' Food and Drug Administration. When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant™. Bazedoxifene's combination with conjugated estrogens, Aprela™, is currently undergoing Phase III studies.

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Wyeth received an approvable letter for Bazedoxifene in late April 2007. The FDA called for final safety and efficacy data from Phase III studies, and acceptable valuation of manufacturing and testing facilities where problems were found earlier in the year. Wyeth is working with the FDA to resolve these issues, and expects an FDA action date at year end.^{[citation needed]}

CITATIONS

BROWN, EMILY. Wyeth's osteoporosis drug cut risk of new fractures. Retrieved on 2007-09-28. Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis. Retrieved on 2007-09-28.