DURAMED WITHDRAWS NDA FOR LO SEASONALE

Duramed Pharmaceuticals has withdrawn its new drug application (NDA) for Lo Seasonale (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg) extended-cycle oral contraceptive for the prevention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 FDA regarding the 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.