Wyeth has received an approvable letter from the FDA for its oral contraceptive Lybrel, stating that the drug candidate cannot be approved until additional data are submitted.
Wyeth is seeking marketing approval for Lybrel, an investigational low dose combination oral contraceptive for women have no known contraindications for this method of contraception.
If approved, this investigational product will contain a low daily dose of ethinyl estradiol and levonorgestrel, a well-studied combination. It is expected to be the only combination oral contraceptive approved with this regimen (...)

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