Miudella FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 26, 2025.

FDA Approved: Yes (First approved February 24, 2025)
Brand name: Miudella
Generic name: copper
Dosage form: Intrauterine System
Company: Sebela Pharmaceuticals, Inc.
Treatment for: Birth Control

Miudella is a copper-containing intrauterine device (IUD) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.

• Long-acting reversible contraceptive (LARC) methods, including intrauterine devices and contraceptive implants, are considered to be effective methods of contraception, and are appropriate for almost all patients.
• Miudella is a next-generation, hormone-free, low-dose copper IUD, with a flexible frame made of nitinol, a material that has superelastic properties that enables strategic placement of the copper in a manner that allows the device to achieve similar efficacy to the currently available Paragard copper IUD with less than half the dose of copper.
• Miudella was studied in three clinical trials in the U.S. in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter single-arm open-label study was conducted in 42 centers in the U.S. with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). In the efficacy cohort from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60) or 99% efficacy.
• Miudella is inserted into the fundus of the uterine cavity, and must be removed or replaced after 3 years.
• Miudella comes with a Boxed Warning for complications due to improper insertion. Miudella is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Miudella REMS program to ensure healthcare providers are trained on the proper insertion of Miudella prior to first use.
• Warnings and precautions associated with Miudella include risk of ectopic pregnancy; increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs; sepsis; pelvic inflammatory disease; perforation resulting in embedment or translocation;  partial or complete expulsion; and altered bleeding patterns.
• Common adverse reactions (incidence ≥ 5%) include heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post procedural hemorrhage, dyspareunia.

Development timeline for Miudella

Further information

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