The U.S. Food and Drug Administration has approved the first generic version of AbbVie Inc.’s Restasis, a medication for dry eye.
“Restasis 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,” said Sally Choe, Ph.D., 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. Supporting development and expanding opportunities to bring complex generic drugs to the market is a major focus of our efforts to help improve competition and help lower drug prices.”
The sponsor of the generic version of cyclosporine ophthalmic emulsion 0.05% single-use vials is Mylan Pharmaceuticals Inc.
Reuters reports that Restasis brought AbbVie revenue of $1.29 billion in 2021.
Keratoconjunctivitis sicca, or dry eye, happens when a person’s eyes don’t make enough tears to stay wet, or when the tears are not of the correct consistency. Cyclosporine ophthalmic emulsion is a commonly prescribed immunomodulator with anti-inflammatory effects that generally helps to increase tear production in these patients.