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February 04, 2022
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FDA approves first Restasis generic

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The FDA has approved the first generic version of Restasis, according to a press release.

Perspective from Francis S. Mah, MD

Cyclosporine ophthalmic emulsion 0.05% increases tear production in patients with dry eye disease. The generic option is sponsored by Mylan Pharmaceuticals.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock

“Restasis [Allergan] has been approved for use in the U.S. 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,” Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, said in the release. “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.”