Barr Withdraws FDA Application For Approval Of Extended Cycle Contraceptive Lo Seasonale

Barr Laboratories on Thursday announced it has withdrawn its FDA application for its extended-cycle oral contraceptive Lo Seasonale, Reuters reports (Reuters, 4/6). The pharmaceutical company said that discussions with FDA led them to realize that more clinical trials would be needed for Lo Seasonale -- the low-dose version of its extended-cycle oral contraceptive Seasonale -- to receive approval (AP/Houston Chronicle, 4/6). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003. Women take 84 active pills consecutively and then take seven placebo pills compared with the usual regimen of 21 active pills with seven placebos (Kaiser Daily Women's Health Policy Report, 8/22/05). Bruce Downey, chair and CEO of Barr, in a release said that the company made the "strategic decision" to withdraw the application so that it could focus on the approval of its extended-cycle oral contraceptive Seasonique, adding that the company "remain's committed to developing a franchise of extended-cycle products" (Barr Laboratories release, 4/6). Barr in August 2005 announced it received an "approvable letter" from FDA for Seasonique, which uses a 0.01 milligram dose of estrogen in place of the placebo pills (Kaiser Daily Women's Health Policy Report, 8/22/05).

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