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, 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|
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