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Sun Pharma receives USFDA acceptance for new drug application

The US health regulator has accepted a new drug application (NDA) for an ophthalmic solution, which was filed by Sun Pharma’s wholly owned subsidiary.

In a BSE filing the company stated, “The US Food and Drug Administration (USFDA) has accepted a new drug application (NDA), filed by its wholly owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution).”

Further, Dilip Shanghvi, MD Sun Pharma stated, “OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing under-served 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.”

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