Posted by Michael Wonder on 28 Dec 2017
Sun Pharma announces US FDA acceptance of NDA for OTX-101
27 December 2017 - OTX-101 is being evaluated for treatment of dry eye disease.
Sun Pharmaceutical Industries announces that the US FDA has accepted a new drug application, 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.
