USFDA accepts Sun Pharma arm’s ophthalmic drug application

NEW DELHI, Dec 27: The US health regulator has accepted a new drug application (NDA) for an ophthalmic solution filed by Sun Pharma’s wholly-owned subsidiary, the drugmaker said today.
“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),” Sun Pharmaceutical Industries said in a BSE filing.
“OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate,” it added.
Sun Pharma MD Dilip Shanghvi said: “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.”
OTX-101 is being developed for global markets.
Sun Pharma said that post the USFDA approval, OTX-101 will be commercialised in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary, which markets BromSite to eyecare practitioners across the US.


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