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# FDA Approves Mirena IUD Duration of Use sNDA
- URL: https://www.fdaweb.com/fda-approves-mirena-iud-duration-of-use-snda/
- Published: 2021-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:11:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150013

FDA has approved a sNDA extending to seven years the duration of use for pregnancy prevention of Bayer’s Mirena (levonorgestrel-releasing intrauterine (IUD) system) 52 mg. The company [says](mailto:ttps://www.marketwatch.com/press-release/fda-label-updates-reflect-bayers-commitment-to-womens-healthcare-2021-08-25?tesla=y) the approval was based on the results of a Phase 3 extension trial evaluating Mirena’s safety and efficacy.

Bayer says Mirena, approved in 2000, is the first hormonal IUD to be approved for use in the U.S. It is currently approved to prevent pregnancy for up to six years. It also is the only FDA-approved IUD to treat heavy periods for up to five years in women who choose intrauterine contraception and can be used in women whether or not they have previously given birth, Bayer says.