Barr Pharmaceuticals says the FDA has issued an "approvable" letter for Duramed's Seasonique and is preparing to provide additional information on the oral contraceptive requested by the agency. "We are pleased that the agency has determined that our Seasonique extended-cycle oral contraceptive product is approvable for the prevention of pregnancy, which was the clinical endpoint of our original study," said Bruce L. Downey, Barr's chairman and CEO. "We intend to seek a meeting with the Agency within the next 30 days to discuss our on-going studies of Seasonique and how they might satisfy FDA's request for additional information."
- read this press release for more information