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Mirena FDA Approval History

FDA Approved: Yes (First approved December 6, 2000)
Brand name: Mirena
Generic name: levonorgestrel
Dosage form: Intrauterine System
Company: Bayer HealthCare Pharmaceuticals, Inc.
Treatment for: Birth Control, Abnormal Uterine Bleeding

Mirena (levonorgestrel) is a progestin-containing intrauterine system indicated for intrauterine contraception for up to 8 years, and for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to 5 years.

Development timeline for Mirena

DateArticle
Aug 18, 2022Approval FDA Approves Extension of Mirena (levonorgestrel-releasing intrauterine system) Intrauterine Device (IUD) for up to Eight Years of Pregnancy Prevention
Aug 25, 2021Approval FDA Approves Extension of Mirena (levonorgestrel-releasing intrauterine system) Intrauterine Device (IUD) for up to Seven Years of Pregnancy Prevention
Oct  2, 2009Approval FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users
Dec  6, 2000Approval FDA Approves Mirena (levonorgestrel-releasing intrauterine system) Long-Acting Contraceptive

See also

Mirena (levonorgestrel) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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