FDAnews Drug Daily Bulletin

DURAMED WITHDRAWS NDA FOR LO SEASONALE

April 17, 2006
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Barr Pharmaceuticals subsidiary Duramed Pharmaceuticals has withdrawn its new drug application (NDA) for Lo Seasonale extended-cycle oral contraceptive for the prevention of pregnancy in women who choose to take hormone products.

The decision to withdraw the pplication resulted from the firm's ongoing discussions with the FDA regarding Lo Seasonale (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg) and Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptives.

Based on those discussions, an dditional, larger clinical trial may be necessary to support continued consideration of the Lo Seasonale application, Barr said April 6. "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 Downey, chairman and CEO of Barr.