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# Allergan Asks for Restasis ANDA Restrictions
- URL: https://www.fdaweb.com/allergan-asks-for-restasis-anda-restrictions/
- Published: 2017-08-09T12:00:00.000Z
- Updated: 2026-09-14T22:40:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139344

Allergan is petitioning FDA 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 petition also asks that the agency: 

- to the extent that it believes a scientifically valid *in vitro*\-only approval pathway exists, refuse to approve any such ANDA until at least 60 days after publication of a final guidance on cyclosporine ophthalmic emulsion that provides an explicit, validated, and detailed description of the testing requirements, the scientific basis supporting those requirements, and associated regulatory criteria;
- refuse to approve any cyclosporine ophthalmic emulsion ANDA until at least 60 days after it has developed and publicly announced scientifically valid final guidelines for the evaluation and approval of generic versions of non-biological complex drugs and after allowing the public at least 30 days to comment;
- before approving any cyclosporine ophthalmic emulsion ANDA, publicly identify in detail all tests, standards, and criteria that FDA is using, or intends to use, in evaluating such ANDAs;
- post all protocols, analytic results, and analytical reports related to specified research at least 60 days before approving any cyclosporine ophthalmic emulsion ANDA; and
- several other items.

“FDA has stated its desire to approve ANDAs for products that claim to be bioequivalent to Restasis without any need for human clinical confirmation,” Allergan says. “However, the evolving *in vitro* approaches that the agency has described over the course of multiple revised draft guidances are built upon circular logic and inconsistent statements, as well as lacking fundamental data to define and support this approach. The agency’s application of the statutory bioequivalence requirement in product-specific contexts must at all times operate in accordance with the governing law and be ‘based on a reasonable and scientifically supported criterion.’ The agency simply has not met these burdens to date.”