Bayer Mirena gets USFDA nod for extended use as contraceptive
LNG-IUS is one of the most effective birth control methods as it does not require user interventions such as daily dosing or monthly re-fills.
Berlin: Bayer, has announced that the supplemental New Drug Application (sNDA) for the extended use up to eight years in the indication, contraception was approved for its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena by the U.S. Food and Drug Administration (USFDA). This approval is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of...
Berlin: Bayer, has announced that the supplemental New Drug Application (sNDA) for the extended use up to eight years in the indication, contraception was approved for its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena by the U.S. Food and Drug Administration (USFDA). This approval is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of Mirena which demonstrated that contraceptive efficacy during years six to eight remains high.
Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus.
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