Published in Physician Law Weekly, May 3rd, 2006
The decision to withdraw the application resulted from the company's ongoing discussions with the U.S. Food & Drug Administration (FDA) 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...
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