The Food and Drug Administration has approved a supplemental New Drug Application to extend the duration of use for Liletta (levonorgestrel-releasing intrauterine system) 52 mg, for up to 4 years.
The approval, issued Aug. 3, adds 1 year to the duration of use on the drug label. It is based on additional efficacy and safety data from ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an Intrauterine System), an ongoing phase 3 trial with 1,751 U.S. women.
There are three other levonorgestrel-releasing IUDs currently on the market: Mirena and Kyleena, which are both approved for up to 5 years of use; and Skyla, which is approved for up to 3 years of use.
mschneider@frontlinemedcom.com
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