The FDA handed Wyeth a third approvable letter for bazedoxifene, a treatment for postmenopausal osteoporosis. In the letter, the FDA said it needed more information concerning the incidence of stroke and venous thrombotic events. Wyeth said the delay was expected. "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," said Gary L. Stiles, M.D., Wyeth's CMO. The company expects to file a response by the end of 2008. A recent IMS report predicted that bazedoxifene could become a much-needed blockbuster for Wyeth if approved.
- see this release
- here's the IMS report
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