BAYRY - Bayer's contraceptive IUD Mirena gets FDA nod for longer use
- The U.S. Food and Drug Administration approved extending the duration of use of Bayer's ( OTCPK:BAYRY ) ( OTCPK:BAYZF ) contraceptive intrauterine device (IUD) Mirena by one more year, making it available to prevent pregnancy for up to eight years.
- The German company said the approval of its supplemental new drug application (sNDA) was backed by data from a phase 3 extension trial evaluating the efficacy and safety of Mirena.
- Bayer noted that Mirena was the first hormonal IUD to be approved in the U.S. in 2000 to prevent pregnancy for up to seven years and works by releasing small amounts of progestin hormone called levonorgestrel into the uterus. The device is also the only FDA-approved IUD to treat heavy periods for up to 5 years, according to the company.
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Bayer's contraceptive IUD Mirena gets FDA nod for longer use