Wyeth receives FDA letter for osteoporosis treatment bazedoxifene
Wyeth Pharmaceuticals, says the FDA has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
Wyeth Pharmaceuticals, says the FDA has issued an approvable letter for bazedoxifene, a selective estrogen receptor modulator, for the treatment of postmenopausal osteoporosis.
In the letter, the FDA requested information similar to that outlined in its approvable letter for bazedoxifene's New Drug Application (NDA) 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, Wyeth Pharmaceuticals said. 'Today's action is in line with our expectations. In our conference with the Agency earlier this year, they stated their desire to convene an advisory committee to review the pending new drug applications for both treatment and prevention of postmenopausal osteoporosis. 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."