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# Bayer Files sNDA to Extend Mirena’s Use
- URL: https://www.fdaweb.com/bayer-files-snda-to-extend-mirenas-use/
- Published: 2019-10-21T12:00:00.000Z
- Updated: 2026-09-15T01:57:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145294

Bayer has submitted a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg. The submission seeks to extend the indication to up to six years of pregnancy prevention based on results from a Phase 3 extension trial evaluating Mirena’s efficacy and safety. The product is currently approved to prevent pregnancy for up to five years. Mirena is also indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of birth control. The company says it should be replaced after five years.