Wyeth Pharmaceuticals, a division of Wyeth has announced a regulatory update for Viviant.
Wyeth has submitted to the US Food and Drug Administration (FDA) clinical study reports of two recently completed clinical studies of Viviant conducted in Asia. These data supplement Wyeth's pending New Drug Application (NDA) 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 for this NDA.
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. The current action date for the prevention NDA is at the end of December 2007, and no labelling discussions have occurred to date. FDA may issue an action letter by year-end 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.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, haemophilia, oncology, vaccines and nutritional products.