WOODCLIFF, N.J., April 6 (UPI) -- Barr said Thursday its subsidiary, Duramed, withdrew its new drug application for contraceptive Lo Seasonale.
Barr said the decision to withdraw the extended-cycle birth-control pill was made after discussions with the Food and Drug Administration indicated an additional, larger clinical trial may be necessary to support the Lo Seasonale NDA.
"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 3 clinical trials," said Bruce Downey, Barr's chairman and chief executive officer.
Barr announced in March that the FDA would not require additional clinical studies to support the approval of Seasonique. Barr said it "is continuing to work with FDA to resolve outstanding issues including product labeling and post marketing commitments, and working toward the ultimate launch of Seasonique in the near future."
Barr said it anticipates filing the Lo Seasonique NDA by the end of 2007.
