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# FDA Accepts for Filing Liletta sNDA
- URL: https://www.fdaweb.com/fda-accepts-for-filing-liletta-snda/
- Published: 2018-02-22T12:00:00.000Z
- Updated: 2026-09-14T23:24:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140820

FDA has accepted for filing a Medicines360 sNDA to extend the duration of use of its Liletta (levonogestrel-releasing intrauterine system) 52 mg from up to four years to up to five years. The company says the sNDA is currently being reviewed by the agency based on additional efficacy and safety data from the ACCESS IUS trial of 1,751 women receiving Liletta.

Liletta is described as a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to four years. It was first approved 2/2015 and jointly launched by Medicines360 and Allergan. An additional 1/2016 FDA approval was for its single-handed inserter. The duration of use to prevent pregnancy was approved for up to four years 8/2017.