- Approval Reinforces Viatris’ Steadfast Commitment to Breaking Down Barriers and Expanding Access to Complex Generic Products
- Milestone Achieved After Decade-Long Investment in Product Development and Numerous Legal Victories
- The Company is Launching Immediately
Viatris Inc. (NASDAQ: VTRS) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion 0.05%, the first generic version of Allergan’s Restasis®. There are no remaining legal or regulatory barriers, and the company is launching immediately.
Viatris President Rajiv Malik said: “I am pleased that Viatris has received the first FDA approval for generic Restasis after working for nearly a decade not only to develop a more affordable product but also to remove all barriers to entry and achieve patient access. We are also proud to add another first to our growing list of industry-setting scientific achievements in bringing to market complex and difficult-to-manufacture products.”
Viatris Developed Markets President Tony Mauro said: “The approval of generic Restasis reinforces our ongoing commitment to deliver innovative solutions and increase access to more affordable treatment options for patients. We look forward to quickly bringing this important product to millions of Americans with chronic dry eye disease.”
Cyclosporine Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, also known as dry eye. Dry eye disease is a common condition that occurs when a patient’s tears are unable to provide adequate lubrication for their eyes. Tears can be inadequate and unstable for many reasons, but the instability can lead to discomfort, inflammation and potential damage of the eye’s surface.