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.

The FDA encourages healthcare providers and patients to report adverse events or quality problems experienced with this product to the FDA's MedWatch Adverse Event Reporting program online or by phone at 1-800-FDA-1088.