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# Bayer sNDA Seeks Mirena Use for 7 Years
- URL: https://www.fdaweb.com/bayer-snda-seeks-mirena-use-for-7-years/
- Published: 2020-10-14T12:00:00.000Z
- Updated: 2026-09-14T16:32:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147872

Bayer has submitted a supplemental NDA seeking to extend the duration of use for its intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) 52 mg. In August, the agency approved Mirena for up to six years of pregnancy prevention. The new submission will seek to extend the indication another year for up to seven years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the Mirena’s efficacy and safety.

The product was first approved in the U.S. in 2000.