Sun Pharma shares rise 7% after USFDA accepts new drug application
Sun Pharma shares closes 6.89% higher at Rs577.70 after the company announces that the USFDA has accepted a new drug application for OTX-101
New Delhi: Shares of Sun Pharmaceuticals Industries Ltd rose nearly 7% after the company disclosed that the US Food and Drug Administration (USFDA) has accepted a new drug application for OTX-101, used for the treatment of dry eye disease.
On Wednesday, the stock closed 6.89% higher at Rs577.70 on BSE, while the Sensex ended 0.29% lower at 33,911.81 points. In intraday trade, the company’s shares surged 9.16% to Rs590.
“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," Sun Pharma said in a BSE filing.
OTX-101, which is now under review for approval by the USFDA, marks an important developmental milestone for Sun Pharma’s dry eye candidate, it added. Once approved by the USFDA, the drug will be commercialized in the US by Sun Ophthalmics, the ophthalmics division of Sun Pharma’s New Jersey-based unit.
“OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic Dry Eye market," said Dilip Shanghvi, managing director, Sun Pharma. “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."
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