FDA Accepts Unicycive’s Oxylanthanum Carbonate NDA Resubmission
The FDA accepted Unicycive Therapeutics’ NDA resubmission for oxylanthanum carbonate and set a PDUFA date of March 25, 2027.
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05:46:15 AM UTC
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Unicycive Therapeutics said the FDA accepted its resubmitted NDA for oxylanthanum carbonate as a Class II review and set a PDUFA target action date of Mar 25, 2027. The resubmission includes CMC data from a new third-party drug product manufacturer.Material DetailsContext by AI AnalystThis is a reg…