Dyspareunia Due to Menopause

• FDA approval · 2024-02-15
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approves a supplemental application for OSPHENA (ospemifene) submitted by Duchesnay USA, Inc.

• FDA approval · 2019-01-25
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  The FDA approved a supplemental application for Osphena (ospemifene) from Duchesnay USA, Inc., likely updating its indications or labeling.

• FDA approval · 2016-11-16
  FDA Approved: INTRAROSA — Original Application (Millicent US, Inc.)

  FDA approved INTRAROSA (prasterone) from Millicent US, Inc. as an Original Application (NDA 208470) for the treatment of dyspareunia due to …

• FDA approval · 2013-02-26
  FDA Approved: OSPHENA — Original Application (Duchesnay USA, Inc.)

  FDA approved Osphena (ospemifene) from Duchesnay USA, Inc. under its original NDA for the treatment of dyspareunia due to menopause.