FDA approves Mylan’s generic Restasis

The Food and Drug Administration has approved Mylan’s generic Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials (eye drops) to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, commonly known as dry eye.

Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs, the company said. 

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“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, director of the office of generic drugs in the Food and Drug Administration’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,” Choe said. “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.”

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.

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This condition, affecting millions of Americans each year, can make the eyes feel uncomfortable. Cyclosporine ophthalmic emulsion is a commonly prescribed immunomodulator, which affects the functioning of the immune system, with anti-inflammatory effects that generally help to increase tear production in these patients, the company said.