Posted by Michael Wonder on 25 Aug 2021
FDA label updates reflect Bayer’s commitment to women’s healthcare
25 August 2021 - FDA approves extension of intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years of pregnancy prevention.
Bayer today announced the U.S. FDA approved a supplemental new drug application that extends the duration of use for its market leading intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg by one year, making it available to prevent pregnancy for up to seven years.
The approval is based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
