FDA Approves First Generic of Restasis

Food and Drug AdministrationFood and Drug Administration

WASHINGTON, D.C. — The U.S. Food and Drug Administration recently approved the first generic of 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.

“Restasis has been approved for use in the U.S. for nearly 20 years, but… 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. “[The] 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.”

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

The most common side effect reported in the clinical trials for Restasis was ocular burning. Other reactions included conjunctival hyperemia (dilation and redness of blood vessels in the eye), discharge, epiphora (excessive watering of the eye), eye pain, foreign body sensation (the sensation of having something in your eye), pruritus (itchy skin), stinging and visual disturbance (most often blurring).

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Applicants must submit appropriate data and information to demonstrate that generic drug products meet the FDA’s rigorous approval standards, ensuring that generic drug products are safe, effective and meet the same high-quality standards as their brand name counterparts.

The development of complex generics may be more difficult due to, for example, their complex active ingredient formulation or route of delivery. As a result, many complex drugs lack generic competition. The FDA has taken a multifaceted approach to encourage development of complex generics through the Generic Drug User Fee Amendments (GDUFA) program.

As part of the GDUFA Science and Research Program, beginning in 2012, the FDA started conducting research to support the development of bioequivalence recommendations for cyclosporine ophthalmic emulsion. In addition to informing the FDA’s draft product-specific guidance on cyclosporine ophthalmic emulsion 0.05%, the FDA’s research program has helped address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis. To date, the FDA has supported 16 research projects related to cyclosporine ophthalmic emulsion.

Addressing the challenges related to developing complex generic drug products, and helping promote more generic competition to complex drug products, is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help promote patient access to more affordable medicines.

The sponsor of the generic cyclosporine ophthalmic emulsion 0.05% single-use vials approved is Mylan Pharmaceuticals Inc.

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