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# Petition Seeking Tighter Restasis ANDA Bioequivalence Denied
- URL: https://www.fdaweb.com/petition-seeking-tighter-restasis-anda-bioequivalence-denied/
- Published: 2016-02-12T12:00:00.000Z
- Updated: 2026-09-15T02:35:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134748

> FDA has denied an Allergan [citizen petition](http://www.regulations.gov/?ref=fdaweb.com#%21documentDetail;D=FDA-2015-P-0065-0001) that had asked the agency not to approve ANDAs for Restasis (cyclosporine ophthalmic emulsion) unless certain conditions are met. The petition had asked that FDA, among other things, not approve such ANDAs if they only contain *in vitro* demonstrations of bioequivalence.  
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> In its [denial letter](http://www.regulations.gov/contentStreamer?documentId=FDA-2015-P-1404-0007&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), the agency said that as long as the generic product has the same qualitative and quantitative composition as the reference-listed drug (RLD) and its physiochemical properties and *in vitro* drug release characteristics are also comparable to the RLD, then *in vitro* testing should suffice to demonstrate bioequivalence. FDA says this method is acceptable regardless of whether there are established *in vitro-in vivo* correlations for the measured physiochemical properties or *in vitro* drug release characteristics.