USFDA accepts NDA filed by Sun Pharma’s arm for OTX-101

27 Dec 2017 Evaluate

The US Food and Drug Administration (USFDA) has accepted a New Drug Application (NDA) filed by Sun Pharmaceutical Industries 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 USFDA, marking an important developmental milestone for Sun Pharma’s dry eye candidate.

Post the USFDA 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. Sun Ophthalmics, founded in 2015, currently markets BromSite (bromfenac ophthalmic solution) 0.075% to eye care practitioners across US.

Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.


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