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# Imvexxy Bioquivalence Guidance Sought
- URL: https://www.fdaweb.com/imvexxy-bioquivalence-guidance-sought/
- Published: 2018-12-12T12:00:00.000Z
- Updated: 2026-09-15T00:50:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143024

TherapeuticsMD is asking FDA not to receive or approve any ANDA that references Imvexxy (estradiol vaginal inserts) unless the ANDA sponsor provides data consistent with the bioequivalence requirements suggested in the TherapeuticsMD [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-4714-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com). The company also asks the agency to issue a product-specific bioequivalence guidance for Imvexxy. It notes that product-specific guidances already have been issued for four other estradiol products.

Specifically, TherapeuticsMD says any ANDAs should demonstrate for each strength that it is Q1/Q2 same and Q3 similar to Invexxy by submitting data from these studies: a bioequiovalence study with pharmacokinetic endpoints; low surfactant dissolution testing; and a bioequivalence study with clinical endpoints. The petition also seeks specific elements in the bioequivalence study with clinical endpoints.

“If the formulation of a proposed drug product referencing Imvexxy is not Q1/Q2 and Q3 to Imvexxy, then bioequivalence cannot be established through existing bioequivalence test methods, and FDA should refuse to receive an ANDA for the drug product,” the company says.