New Delhi: 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 commercialized in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma’s wholly owned subsidiary, which markets BromSite to eyecare practitioners across the US.
Shares of Sun Pharma were up 5.75 percent at Rs 571.55 on the BSE.