Heavy Menstrual Bleeding

• FDA approval · 2025-12-17
  FDA Approved: ORIAHNN — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for ORIAHNN, a fixed-dose combination of elagolix, estradiol, and norethindrone by AbbVie. The appro…

• FDA approval · 2021-05-26
  FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for Mirena (levonorgestrel) by Bayer HealthCare Pharmaceuticals Inc. under NDA 021225. This action u…

• FDA approval · 2019-07-17
  FDA Approved: TRANEXAMIC ACID — Original Application (Caplin Steriles Limited)

  FDA approves Caplin Steriles Limited's generic tranexamic acid via an original application (ANDA 212360).

• FDA approval · 2009-10-01
  FDA Approved: MIRENA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA granted approval for a supplemental application for MIRENA (levonorgestrel intrauterine system) submitted by Bayer HealthCare Pharma…