Unicycive Receives FDA CRL Over Third-Party Manufacturing Deficiencies for OLC
UNCY•Unicycive Therapeutics received an FDA Complete Response Letter for its resubmitted NDA of oxylanthanum carbonate due to unresolved third-party manufacturing deficiencies, although no additional clinical efficacy or safety data were requested. The company is negotiating label and packaging details and anticipates an inspection of the manufacturing vendor before expeditious resubmission.
1. FDA Complete Response Letter Details
Unicycive received a Complete Response Letter highlighting that its resubmitted NDA for oxylanthanum carbonate does not include resolution of previously cited deficiencies at a third-party manufacturing facility. The FDA did not request additional clinical efficacy or safety data, focusing solely on manufacturing compliance.
2. Pending Third-Party Vendor Inspection
The resubmitted NDA review was completed without an onsite inspection of the manufacturing vendor, leaving outstanding validation of its corrective actions. Unicycive’s original vendor has been working on remediation since June 2025, and the FDA has yet to schedule a follow-up inspection.
3. Labeling Discussions and Resubmission Plans
Unicycive is engaged in detailed discussions on carton and container labeling requirements, aiming to address all administrative aspects before resubmission. The company expects a successful inspection and plans to expeditiously resubmit the NDA once the vendor is inspection-ready.
