The Food and Drug Administration has accepted for review a new drug application from Barr for its Seasonale extended-regimen oral contraceptive

Drug Store News, Oct 7, 2002

The Food and Drug Administration has accepted for review a new drug application from Barr for its Seasonale extended-regimen oral contraceptive. This represents Barr's first NDA filing. Barr stated that Seasonale extended-regimen oral contraceptive is a patent-protected oral contraceptive product being developed through an agreement with Eastern Virginia Medical School.

Under the Seasonale regimen, women take active tablets for up to 84 consecutive days, followed by a seven-day placebo interval. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.