Drug Information Update- FDA Approves Mirena (levonorgestrel intrauterine system) to Treat Heavy Menstrual Bleeding in IUD Users

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Title: Drug Information Update- FDA Approves Mirena (levonorgestrel intrauterine system) to Treat Heavy Menstrual Bleeding in IUD Users

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.

For more information, please visit: Mirena


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