Unicycive resubmits FDA NDA for oxylanthanum carbonate phosphate binder
UNCY•Unicycive resubmitted its FDA NDA for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. The filing includes manufacturing data from a new vendor, and a new PDUFA date is expected in six months.
1. FDA resubmission
Unicycive resubmitted its FDA application for oxylanthanum carbonate, a phosphate binder for hyperphosphatemia in patients with chronic kidney disease who are on dialysis. The filing includes chemistry, manufacturing and controls data from a new manufacturing vendor, with a new PDUFA date expected in six months.
2. Prior FDA feedback
The FDA issued complete response letters in June 2025 and June 2026 citing deficiencies at a third-party manufacturer. The agency raised no issues with clinical efficacy or safety.
