Wyeth submitted additional data to FDA ahead of a scheduled late December action date for Viviant (bazedoxifene) in prevention of postmenopausal osteoporosis.

The data supplements a complete response to an FDA "approvable" letter filed in July.

The firm notes in a Dec. 14 news release that "no labeling 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 latest filing includes clinical study reports from recently completed trials in Asia.

In April, the company received an "approvable" letter from FDA seeking fracture data from a three-year pivotal trial and evaluation of Wyeth's Guayama, Puerto Rico, manufacturing facility (¹ Also see "Wyeth’s Viviant “Approvable” For Prevention Of Postmenopausal Osteoporosis" - Pink Sheet, 24 April, 2007.).

The company submitted a separate NDA in July seeking approval of bazedoxifene for the treatment of postmenopausal osteoporosis. That application has a May 2008 user fee date.

-Brooke McManus (b.mcmanus@elsevier.com)

Wyeth Submits More Viviant Data To FDA

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