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# Medicines360 sNDA for Expanded Contraception Under Review
- URL: https://www.fdaweb.com/medicines360-snda-for-expanded-contraception-under-review/
- Published: 2018-02-22T12:00:00.000Z
- Updated: 2026-09-14T23:24:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140825

FDA has accepted for review a Medicines360 supplemental NDA that seeks to extend the duration of use for preventing pregnancy from up to four years to up to five years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg. The submission is based on additional efficacy and safety data from a Phase 3 hormonal IUD trial in the U.S. (ACCESS IUS) that involved 1,751 women. Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy. Women can use the product whether they have previously given birth and it can be removed at any time by a healthcare provider, the company says.