The decision to withdraw the application was made based on the company’s ongoing discussions with the US Food & Drug Administration regarding the Lo Seasonale NDA and the discussions for its Seasonique extended-cycle oral contraceptive.
Based on those discussions, the company has concluded an additional, larger clinical trial may be necessary to support continued consideration of the Lo Seasonale application.
“Rather than continue to devote additional resources to the Lo Seasonale NDA, we have made the strategic decision to withdraw the application, and concentrate on the approval of Seasonique and the expansion of the Seasonique product franchise with the Lo Seasonique product that is currently in phase III clinical trials,” said Bruce Downey, Chairman and CEO of Barr Pharmaceuticals.