(Recasts, adds details)
CHICAGO Dec 24 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
The FDA requested further analyses and discussion
concerning incidents of stroke and venous thrombotic events.
The agency is also seeking additional source documents, Wyeth
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
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