FDA extends Liletta IUD duration of use to 4 years

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.

The Liletta IUD is marketed by the pharmaceutical company Allergan and the nonprofit women’s health pharmaceutical company Medicines360. It was first approved by the FDA in February 2015 and received agency approval for a single-handed inserter in January 2016. Liletta is available at lower cost to public health clinics enrolled in the federal 340B Drug Pricing Program.

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

On Twitter @maryellenny

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.

The Liletta IUD is marketed by the pharmaceutical company Allergan and the nonprofit women’s health pharmaceutical company Medicines360. It was first approved by the FDA in February 2015 and received agency approval for a single-handed inserter in January 2016. Liletta is available at lower cost to public health clinics enrolled in the federal 340B Drug Pricing Program.

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

On Twitter @maryellenny

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.

The Liletta IUD is marketed by the pharmaceutical company Allergan and the nonprofit women’s health pharmaceutical company Medicines360. It was first approved by the FDA in February 2015 and received agency approval for a single-handed inserter in January 2016. Liletta is available at lower cost to public health clinics enrolled in the federal 340B Drug Pricing Program.

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

On Twitter @maryellenny