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
Further information
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