Sun Pharmaceutical Industries Ltd. announced that the US FDA has accepted a New Drug Application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A,ophthalmic solution) 0.09%, a novel nanomicellar formulation of cyclosporine A 0.09% in a clear,preservative-free aqueous solution.
Dilip Shanghvi, Managing Director, Sun Pharma, said: “OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic Dry Eye market. When approved, it will be a milestone for millions of Dry Eye patients across the globe that are yet to find relief for their condition.”
Post the US FDA approval, OTX-101 will be commercialized in the US by Sun Ophthalmics, the brandedophthalmics division of Sun Pharma’s wholly owned subsidiary, based in Princeton, New Jersey.
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