09 Aug LILETTA IUD Approved to Prevent Pregnancy for up to Four Years
Allergan and Medicines360 announced that the Food and Drug Administration (FDA) has approved Liletta (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 4 years. “The newly approved indication for LILETTA is an important milestone in our work to make this IUD available to women, in partnership with Allergan,” said Jessica Grossman, M.D., CEO of Medicines360. “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.”
The FDA’s approval of the supplemental New Drug Application (sNDA) was based on efficacy and safety data from an ongoing Phase 3 ACCESS IUS trial. The study showed Liletta was greater than 99 percent effective in preventing pregnancy in a broad range of women, regardless of age, body mass index, parity, and race.
“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,” said David Nicholson, Ph.D., Chief Research and Development Officer, Allergan. “The FDA’s approval of an extended indication for LILETTA is another step forward for women’s reproductive health options.”
LILETTA is a hormone-releasing IUD (intrauterine device) for women desiring pregnancy prevention for up to 4 years.
It is available exclusively through Anda Incorporated. For more information, call 1-855-LILETTA (1-855-545-3882) or visit LILETTA.com.