Posted by Michael Wonder on 14 Oct 2020
Bayer submits supplemental new drug application to the FDA for intrauterine device Mirena (levonorgestrel releasing intrauterine system) 52 mg
14 October 2020 - Application seeks to extend duration of use up to seven 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.
In August, Mirena received approval from the FDA to extend its indication for up to six years of pregnancy prevention.
This new submission will seek to extend the indication another year for up to seven years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
