"The US Food and Drug Administration (USFDA) has accepted an NDA, filed by its wholly-owned subsidiary, for OTX-101 (cyclosporine A, ophthalmic solution)," Sun Pharmaceutical Industries said in a BSE filing on Wednesday.
OTX-101 is now under review for approval by the USFDA, 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."
At 1:19 pm, shares in Sun Pharma were trading 6.1 per cent at Rs 573.55 apiece on the BSE, whose benchmark Sensex index was up 57 points at 34,068.