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CHICAGO, Dec 24 (Reuters) - Wyeth WYE.N said on Monday U.S. regulators are willing to approve its drug bazedoxifene to prevent osteoporosis in post-menopausal women but requested more analyses on the risk of blood clots and stroke.
In the approvable letter, the U.S. Food and Drug Administration identified several remaining questions but did not ask for any new studies of bazedoxifene, a selective estrogen receptor modulator to prevent bone deterioration in post-menopausal women.
The FDA requested further analyses and discussion concerning incidents of stroke and venous thrombotic events. The agency is also seeking additional source documents, Wyeth said.
The FDA suggested an end-of-review conference to address the remaining issues, the company said.
It is the second approvable letter Wyeth has received for bazedoxifene, whose brand name is Viviant. FDA issued the first approvable letter in April, requiring among other things an evaluation of manufacturing and testing facilities for the drug and an FDA analysis of final safety and efficacy data.
In addition to the prevention indication, Wyeth in July submitted a separate application for a second indication for bazedoxifene, for the treatment of post-menopausal osteoporosis.
Separately, Wyeth said it will sue Teva Pharmaceuticals USA TEVA.O. The drug company claims that Teva’s pantoprazole -- a generic version of Wyeth’s Protonix, which treats heartburn and other stomach ailments -- infringes a patent exclusively licensed to Wyeth.
Wyeth said it will seek “substantial” damages from Teva. (Reporting by Susan Kelly and Chris Reiter; Editing by Brian Moss)