Wyeth Lybrel PDUFA date
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Wyeth expects a decision on its continuous oral contraceptive Lybrel (levonorgestrel/ethinyl estradiol) by June 27 following a 90-day extension by FDA. Lybrel "is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval," the company says...