Allergan (NYSE:AGN) and women’s health nonprofit Medicines360 said today that the FDA approved a supplemental new drug application to extend the duration of use for Liletta, a levonorgestrel-releasing intrauterine device, for up to four years.
The hormone-releasing device was first approved in February 2015 and it won additional approval in January last year for a single-handed inserter.
“The newly approved indication for Liletta is an important milestone in our work to make this IUD available to women, in partnership with Allergan,” Medicines360 CEO Dr. Jessica Grossman said in prepared remarks. “Our mission is to help women access safe and effective contraception, and the new four-year indication for Liletta is good news for women who want the reliability and flexibility that a hormonal IUD can offer.”
“Allergan is committed to advancing options in women’s healthcare, and we are pleased to partner with Medicines360 to further our common goal to offer women effective and safe contraceptives,” David Nicholson, Allergan’s chief research and development officer, added. “The FDA’s approval of an extended indication for Liletta is another step forward for women’s reproductive health options.”