7 August 2017 - Approval offers women additional flexibility for pregnancy prevention.

Allergan and Medicines360 announced that the U.S. FDA approved Medicines360's Supplemental new drug application to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to four years.

The FDA approval was based on a review of additional efficacy and safety data from an ongoing U.S.-based Phase 3 hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS [intrauterine system]), with 1,751 U.S. women receiving Liletta. Liletta was shown to be greater than 99 percent effective in preventing pregnancy in a broad range of women, regardless of age, race, body mass index or parity (whether or not the woman had given birth to at least one child).

Read Allergan press release