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news.Wyeth Pharmaceuticals, a division of Wyeth, has announced that the FDA has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
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In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene’s new drug application for the prevention of postmenopausal osteoporosis issued in December 2007. This included further analyses concerning the incidence of stroke and venous thrombotic events. The Agency also identified specific questions concerning data collection and reporting and requested additional source documents.
Gary Stiles, executive vice president, chief medical officer, Wyeth, said: “We have been working closely with the FDA to address their questions and we are preparing a complete response which we expect to file by end of 2008. We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture.”