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Unicycive Therapeutics resubmitted its FDA NDA for oxylanthanum carbonate phosphate to treat hyperphosphatemia in CKD patients on dialysis, including CMC data from a new manufacturing vendor. FDA issued no clinical efficacy or safety issues, with a new PDUFA date expected in six months after prior CRLs in June 2025 and
Unicycive resubmitted its NDA for oxylanthanum carbonate, expecting FDA acceptance within 30 days and a six—month review clock. The resubmission uses a new CMC vendor with an FDA “No Action Indicated” 2024 inspection.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory update after p…
Unicycive Therapeutics announced the resubmission of its new drug application for oxylanthanum carbonate.