Wyeth Submits More Viviant Data To FDA
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm acknowledges recent submission could push back December user fee date for NDA for prevention of osteoporosis.
You may also be interested in...
Wyeth’s Viviant Receives Second “Approvable” Letter For Osteoporosis Prevention
FDA requests additional data on stroke and thrombotic events in the letter, Wyeth reports.
Wyeth’s Viviant Receives Second “Approvable” Letter For Osteoporosis Prevention
FDA requests additional data on stroke and thrombotic events in the letter, Wyeth reports.
Wyeth’s Viviant “Approvable” For Prevention Of Postmenopausal Osteoporosis
Firm continues to plan an additional submission this year for an osteoporosis treatment claim.