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# Guidance on Cyclosporine Bioequivalence Posted
- URL: https://www.fdaweb.com/guidance-on-cyclosporine-bioequivalence-posted/
- Published: 2016-02-10T12:00:00.000Z
- Updated: 2026-09-15T02:34:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134732

> FDA has released a draft guidance on *Cyclosporine Bioequivalence Recommendations* for generic cyclosporine 0.05% emulsion/ophthalmic products. The document offers two options — an *in vitro* or *in vivo* study for demonstrating bioequivalence. The agency says that in order to qualify for the *in vitro* option, the test and reference-listed drug (RLD) formulations should be qualitatively and quantitatively the same. Also, the comparative study should be performed on at least three exhibit lots of both test and RLD products.