Bayer's long-term contraceptive Skyla garners FDA approval

Bayer's low-dose levonorgestrel-releasing intrauterine system Skyla has been approved by the FDA, the company announced Thursday. The product will be launched in the US starting next month.

Approval is supported by data from a Phase III trial of 2884 women aged 18 to 35, including 1432 who received Skyla. Results showed that Bayer's product was more than 99 percent effective in preventing pregnancy, while 77 percent of women wishing to become pregnant did so within 12 months of its removal.

The system, which is placed in the uterus for the prevention of pregnancy for up to three years, recently completed the registration process in Europe, where it will be marketed as Jaydess.

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