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# FDA Denies Allergan Petition on Restasis Bioequivalence
- URL: https://www.fdaweb.com/fda-denies-allergan-petition-on-restasis-bioequivalence/
- Published: 2018-01-03T12:00:00.000Z
- Updated: 2026-09-14T23:10:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140401

FDA has denied an 8/2017 Allergan petition asking it to refuse to approve any pending ANDA for cyclosporine ophthalmic emulsion for which its Restasis is the reference-listed drug that relies on *in vitro* or other non-clinical analyses, and does not rely on one or more appropriately designed clinical endpoint bioequivalence studies, as previously suggested by FDA, to demonstrate bioequivalence to Restasis. The agency noted that Allergan raised similar issues in two 2014 petitions that were denied, and it declined to address those again in this [denial action](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-4745-0026&contentType=pdf&ref=fdaweb.com). FDA did indicate it will take into consideration Allergan concerns about demonstrating bioequivalence when it works to finalize its current draft guidance on cyclosporine bioequivalence.