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Bazedoxifene did not increase breast tenderness endocrinetoday.com |
Bazedoxifene is a selective estrogen receptor modulator (SERM), under development by Pfizer following the completion of their takeover of Wyeth Pharmaceuticals. Pfizer are seeking approval for bazedoxifene in the prevention and treatment of postmenopausal osteoporosis[1]. Bazedoxfiene is the result of an exclusive research collaboration between Wyeth Pharamceuticals and Ligand Pharmaceuticals. It is approved in the European Union, and is currently in the late phases of review by the United States' Food and Drug Administration. When approved, bazedoxifene is to be sold by Wyeth under the tradename Viviant in the US and Conbriza in the EU. Bazedoxifene's combination with conjugated estrogens, Aprela, is currently undergoing Phase III studies. [edit] History of approvalWyeth 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 was working with the FDA to resolve these issues, and expected an FDA action date at the end of 2007. As of July 2009, the FDA have not given approval for the use of bazedoxifene in the US.[2] The drug was approved in the European Union by the European Medicines Agency on April 27, 2009.[3] [edit] References
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