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Nicox submits new drug application for AC-170

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Nicox has submitted a new drug application to the FDA for AC-170 to treat ocular itching associated with allergic conjunctivitis, according to a press release.

The company also requested a priority review based on clinical pediatric data generated with AC-170, a cetirizine eye drop formulation.

“If successful in obtaining priority review, we would have two compounds — AC-170 and latanoprostene bunod, licensed to Bausch + Lomb — potentially receiving FDA approval in the United States by the end of 2016. This would be a remarkable achievement for Nicox,” Michele Garufi, chairman and CEO of Nicox, said in the release.

The FDA has a 60-day filing review period to determine if the NDA is complete and acceptable for filing and to grant the priority review.