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Osphena Approval History

FDA Approved: Yes (First approved February 26, 2013)
Brand name: Osphena
Generic name: ospemifene
Dosage form: Tablets
Company: Duchesnay Inc.
Treatment for: Dyspareunia, Atrophic Vaginitis

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

Development History and FDA Approval Process for Osphena

DateArticle
Jan 29, 2019Approval FDA Approves Osphena (ospemifene) for Moderate to Severe Vaginal Dryness Due to Menopause
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

Further information

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