Sun Pharma announced today morning that 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.

OTX-101 is now under review for approval by the US FDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate.

Post the US FDA approval, OTX-101 will be commercialized in the US by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary, based in Princeton, New Jersey.

Following this news, the stock is among the top five gainers on the BSE. The stock price rose over 6.5% to Rs.576. Volumes are robust at almost 4 times.