FDA accepts for filing sNDA for Liletta 52 mg

Application seeks to extend duration of use up to 4 years for Liletta.

The supplement currently being reviewed by FDA includes additional efficacy and safety data from an ongoing US-based Phase III hormonal IUD trial, ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an 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 (BMI).

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. Liletta systems with the single-handed inserter are commercially available in the US as well as at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.

Liletta is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to 3 years and is greater than 99% effective. Liletta is not permanent; it can be removed at any time by a healthcare provider, offering the flexibility of use for either long- or short-term contraception. LILETTA can be used in women regardless of whether or not they've birthed a child.