Allergan: FDA Accepts For Filing SNDA For Liletta

(RTTNews) - Allergan plc (AGN) and Medicines360, a nonprofit global women's health pharmaceutical company, said that the U.S. Food and Drug Administration has accepted for filing Allergan's supplemental New Drug Application or sNDA for Liletta 52 mg.

The application seeks to potentially extend the duration of use for the prevention of pregnancy from up to three years to up to four years for Liletta, or levonorgestrel-releasing intrauterine system 52 mg.

The supplement currently being reviewed by FDA includes additional efficacy and safety data from an ongoing U.S.-based Phase 3 hormonal IUD trial, ACCESS IUS, with 1,751 women receiving Liletta.

Liletta was shown to be safe and effective for a broad range of women regardless of age, race, parity or Body Mass Index or BMI.

Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years. Liletta was first approved in February 2015 with a two-handed inserter and received additional FDA approval in January 2016 for a new single-handed inserter.