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            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.