The Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05% single-use vials (eye drops), the first generic version of Restasis.

Cyclosporine ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

“Restasis has been approved for use in the US for nearly 20 years, but until today, there was no approved generic product of this drug that can help the millions of Americans who suffer from dry eyes,” said Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s approval reflects the FDA’s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts.” 

Ocular burning was reported as the most common adverse reaction with cyclosporine ophthalmic emulsion use. Clinical trials evaluating Restasis showed that increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.


FDA approves first generic of Restasis. News release. US Food and Drug Administration. Accessed February 2, 2022.