Osphena Approval History

  • FDA approved: Yes (First approved February 26th, 2013)
  • Brand name: Osphena
  • Generic name: ospemifene
  • 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.

FDA Approval History for Osphena

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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