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
|Feb 26, 2013||FDA Approves Osphena for Postmenopausal Women Experiencing Dyspareunia|
|May 9, 2012||Shionogi 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.