Posted by Michael Wonder on 21 Oct 2019
Bayer submits supplemental new drug application to FDA for intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg
21 October 2019 - Application seeks to extend duration of use up to six years for Mirena.
Bayer announced today the submission of a supplemental new drug application to the U.S. FDA to potentially extend the duration of use for its market leading intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg.
The submission seeks to extend the indication to up to six years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
