Wyeth’s Viviant receives second "approvable" letter
This article was originally published in Pharmaceutical Approvals Monthly
FDA requests additional analyses and discussion concerning stroke and venous thrombotic events in studies of Wyeth's Viviant (bazedoxifene), which received its second "approvable" letter Dec. 28. FDA also has several remaining questions that were not fully resolved by the firm's complete response to the first letter. Viviant is under consideration for prevention of postmenopausal osteoporosis, as well as treatment of the disease under a separate NDA submitted in July that carries a May 2008 user fee date...
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