FDA label
What is Osphena used for?
Osphena contains ospemifene. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Osphena lists 2 uses: The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.; The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause..
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Osphena, tablet, film coated
Indications and Usage, quoted from the label by Duchesnay USA, Inc. (NDA203505). Cross-references to other label sections are left out.
OSPHENA is indicated for:
The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.
The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.
Source: DailyMed label, set id 9accbcc9-78ee-4f84-9b7e-704f2ab1c413, version 4, effective February 14, 2025. NDC 55494-580, one of 1 listing for this product.
Questions
What is Osphena used for?
The FDA label for Osphena lists 2 uses: The Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause.; The Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause..
What drug class is Osphena?
FDA lists ospemifene in the Estrogen Agonist/Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.