Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
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.