FDA Expands Approval of Mirena IUD Device

The FDA has expanded its approval of Bayer’s intrauterine device (IUD) Mirena, extending its use by an additional year to prevent pregnancy. The device was previously approved for up to seven years.

The long-acting reversible contraceptive device, which delivers small amounts of progestin hormone called levonorgestrel into the uterus, can be removed at any time by a healthcare provider if a woman's plans change.

The FDA approval of Bayer’s supplemental New Drug Application (sNDA) was based on results from a phase 3 extension trial in which the combination product showed efficacy of more than 99 percent during years 6-8 of use.

The 8-year approval will give women another birth control option to discuss with their healthcare provider, the company said.