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Osphena Approval History

  • FDA approved: Yes (First approved February 26th, 2013)
  • Brand name: Osphena
  • Generic name: ospemifene
  • Dosage form: Tablets
  • Company: Shionogi Inc.
  • Treatment for: Postmenopausal Symptoms

Osphena (ospemifene) is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.

Development History and FDA Approval Process for Osphena

Feb 26, 2013Approval FDA Approves Osphena for Postmenopausal Women Experiencing Dyspareunia
May  9, 2012Shionogi Files a New Drug Application for Ospemifene Oral Tablets 60mg for the Treatment of Vulvar and Vaginal Atrophy

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