FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia

[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy, due to menopause by delivering a low dose of estradiol directly to vaginal tissue. The generic estradiol vaginal inserts are bioequivalent to the reference listed drug Imvexxy® and are available in the same 4 mcg and 10 mcg strengths. Generic drugs undergo rigorous FDA review to ensure they meet the same standards for quality, strength, purity, and stability as brand-name drugs. Generic drugs also have the same active ingredient, dosage form, strength, route of administration, and conditions of use as the brand-name drug. Generic drugs typically cost less than brand-name drugs, providing significant cost savings for patients and the healthcare system. Healthcare providers should review the full prescribing information for complete safety and dosing information.