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news.The FDA has informed Barr Pharmaceuticals that additional clinical data will not be required to support the approval of its new drug application for Seasonique extended-cycle oral contraceptive.
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The company said that it will continue to work with FDA to resolve outstanding issues including product labeling and post marketing commitments.
In August, the FDA issued an approvable letter that requested additional data to support Seasonique’s unique regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen. Once approved, the company intends to market Seasonique for the prevention of pregnancy in women who choose to take hormone products for contraception.
“We will continue to work closely with the Agency to resolve outstanding issues as quickly as possible, and provide the package, labeling and other information they have requested so that the review and approval of this application proceeds as quickly as possible,” said Bruce Downey, Barr’s Chairman and CEO.