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news.Wyeth Pharmaceuticals has submitted to the FDA clinical study reports of two recently completed clinical studies of Viviant conducted in Asia. These data supplement Wyeth's pending new drug application for Viviant for the prevention of postmenopausal osteoporosis and its complete response to the safety and efficacy issues raised in the FDA's April 23, 2007 approvable letter.
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Whether the complete response and this supplemental submission resolve to the FDA’s satisfaction the issues raised in the approvable letter is not yet known, said Wyeth. The current action date for the prevention new drug application (NDA) is at the end of December 2007, and no labeling discussions have occurred to date. According to Wyeth, the FDA may issue an action letter by the end of 2007 or before, or may extend the review period by 90 days as a result of the recent submission.
The FDA action date for Wyeth’s separate NDA for Viviant for the treatment of postmenopausal osteoporosis remains at the end of May 2008.