FDA Approves First Generic of Restasis

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The first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05 percent single-use vials (eye drops) has been approved by the US Food and Drug Administration to increase tear production in patients whose tear production is thought to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (commonly known as dry eye). Patients who were using topical anti-inflammatory medications or wearing punctal plugs did not produce more tears.

“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. 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 the 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,”

said Sally Choe, Ph.D., director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. 

Dry eye, also referred to as keratoconjunctivitis sicca, occurs when a person’s eyes don’t produce enough tears to keep them moist, or when the tears aren’t the right consistency. This illness, which affects millions of Americans each year, can cause discomfort in the eyes. Cyclosporine ophthalmic emulsion is a regularly given immunomodulator (a medication that influences how the immune system works) with anti-inflammatory properties that can help these people produce more tears.

Ocular burning was the most common side effect recorded in Restasis clinical studies. Conjunctival hyperemia (dilation and redness of blood vessels in the eye), discharge, epiphora (extreme watering of the eye), eye pain, foreign body sensation (the sensation that something is in your eye), pruritus (itchy skin), stinging, and visual disruption were among the other effects (most often blurring).

Applicants must provide sufficient data and information to establish that generic drug products meet the FDA’s stringent approval criteria, ensuring that generic drug products are safe, effective, and of the same high quality as their brand-name counterparts.

Complicated generics may be more challenging to develop due to factors such as complex active ingredient formulation or delivery mechanism. As a result, there is no generic competition for many complex medications. Through the Generic Drug User Fee Amendments (GDUFA) program, the FDA has taken a multimodal strategy to encourage the development of complicated generics.

Beginning in 2012, the FDA began undertaking research to support the creation of bioequivalence guidelines for cyclosporine ophthalmic emulsion as part of the GDUFA Science and Research Program. The FDA’s research program has helped address complex issues on the analytical measurement and statistical assessment of a proposed generic product to Restasis, in addition to informing the FDA’s draught product-specific guidelines on cyclosporine ophthalmic emulsion 0.05 percent. The FDA has funded 16 research projects on cyclosporine ophthalmic emulsion so far.

The FDA’s Drug Competition Action Plan and the agency’s actions to help promote patient access to more inexpensive medications include addressing the issues associated with manufacturing complex generic drug products and assisting in the promotion of more generic competition to complex drug products.

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