The subsidiary of Barr Pharmaceuticals, Inc., Duramed Pharmaceuticals, Inc., has withdrawn its New Drug Application (NDA) for Lo Seasonale (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg) extended-cycle oral contraceptive for the prevention of pregnancy in women who choose to take hormone products.

The decision to withdraw the application resulted from the Company's ongoing discussions with the US Food & Drug Administration regarding the Lo Seasonale NDA and the discussions for its Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) 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.

"Our continued communication with the Agency resulting in part from the review of our Seasonique application has provided us with better insight on the magnitude of clinical trials necessary to support our expansion of the extended-cycle oral contraceptive product franchise," said Bruce L. Downey, Chairman and CEO of Barr Pharmaceuticals, Inc. "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. We remain committed to developing a franchise of extended-cycle products, and believe that the Seasonique products will ultimately become the flagships of our extended-cycle oral contraceptive franchise."

The company submitted its Lo Seasonale NDA on June 24, 2005. Under the Prescription Drug User Fee Act (PDUFA), the action date for the Lo Seasonale NDA would have been April 24, 2006.

On March 16, 2006, the company confirmed that the FDA had determined that additional clinical studies would not be required to support the approval of the Seasonique extended-cycle oral contraceptive. The company is continuing to work with FDA to resolve outstanding issues including product labelling and post marketing commitments, and working toward the ultimate launch of Seasonique in the near future.