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FDA sets Sept. 8 for decision on Zerviate NDA

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The FDA has set a PDUFA date of Sept. 8 for its decision on the new drug application for Zerviate, according to a Nicox press release.

Zerviate (cetirizine ophthalmic solution 0.24%) is an eye drop formulation designed to treat ocular itching associated with allergic conjunctivitis.

The company resubmitted the NDA application for Zerviate in March after receiving a complete response letter from the FDA about issues with a third-party facility producing the active pharmaceutical ingredient in the product. Those issues have since been resolved, the release said.