Sun Pharma announces US FDA acceptance of NDA for OTX-101

 

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.

The stock was higher by 6% at Rs. 572.

The stock has hit a high of Rs. 576 and a low of Rs. 543.

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Yash Ved
Yash Ved is a Senior Correspondent at NewsBarons and comes with a decade of experience across leading online and offline publications. A keen observer of the stock index movement, Yash also likes covering Real Estate and the BFSI sector. A financial management and Journalism student, Yash believes learning as a continuous journey and enjoys following the IT and the Pharmaceutical industry and has penned many articles on the subjects.
yash@newsbarons.com
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