FDA Approves Medicines360’s Supplemental New Drug Application for Liletta (levonorgestrel-releasing intrauterine system) 52 mg as Treatment of Heavy Menstrual Bleeding

SAN FRANCISCO, CA — July 10, 2023 — Medicines360, a global nonprofit organization with a mission to catalyze equitable access to quality medicines for women, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for Liletta® (levonorgestrel-releasing intrauterine system) 52 mg for treatment of Heavy Menstrual Bleeding (HMB) for up to five years in patients who choose intrauterine contraception as their method of contraception.

A substantial body of literature has demonstrated the levonorgestrel 52 mg IUS to be highly effective at reducing bleeding in patients with HMB. “For those experiencing HMB, medical treatments are preferred over surgical treatment as they are more convenient and pose less risk,” said Andrea Olariu, M.D., PhD, and CEO of Medicines360. “With limited choices of hormonal IUDs to treat HMB, we are pleased to deliver on our mission by working to offer prescribers and patients another medical treatment option.”

The FDA’s approval of the new indication is based on efficacy and safety data from a Phase 3 clinical trial conducted by Medicines360, which was first published in Obstetrics and Gynecology in May 2023. The clinical trial included study participants of various ages, races, parity, and body mass index (BMI).

Liletta is commercially available in the U.S. through Medicines360’s nonprofit pharmaceutical model. Liletta is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.


Liletta® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 8 years. Liletta also treats heavy periods for up to 5 years in women who choose to use birth control placed in the uterus.


  • Do not use Liletta if you:
    • Are or might be pregnant; Liletta cannot be used as an emergency contraceptive
    • Have a serious pelvic infection called pelvic inflammatory disease (PID); PID occurs in less than 1% of users
      • Have an untreated lower genital infection now
      • Have had a serious pelvic infection after an abortion or pregnancy within the last 3 months
      • Can get infections easily; for example, if you:
        • Have problems with your immune system
        • Have multiple sexual partners or your partner has multiple sexual partners
        • Have a history of PID
        • Have or suspect you might have cancer of the uterus or cervix
        • Have bleeding from the vagina that has not been explained
        • Have short-term (acute) liver disease or liver tumor
        • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
        • Have an intrauterine contraceptive system (IUS) in your uterus already
        • Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors
        • Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate
        • Liletta may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if Liletta comes out. If you think that Liletta has come out, use another birth control method like condoms or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
        • Ovarian cysts may occur but usually disappear
        • Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop

        Liletta does not protect against HIV or STDs.

        Available by prescription only.

        You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

        Please see full Prescribing Information for Liletta.

        About Medicines360

        Posted: July 2023

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        Liletta (levonorgestrel) FDA Approval History

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