Oxylanthanum Carbonate (OLC)

Development notes

9/3/24- Submitted NDA. 11/11/24- FDA accepted NDA with PDUFA date of June 28, 2025. 6/10/25- FDA identified deficiencies in cGMP compliance at 3rd-party mfg vendor. 6/30/25- Received CRL. 10/28/25- Provided update from FDA meeting & timing of NDA resubmission. 11/12/25:- Remain on track to resubmit the NDA for OLC by year-end 2025, with potential for a new PDUFA date in H1 2026. Presented new ASN Kidney Week 2025 analysis showing markedly reduced pill burden versus current phosphate binders. 12/29/25:- Resubmitted OLC NDA. Expect FDA acceptance decision within 30 days and 6-month review timeline per guidelines. 01/29/26:- FDA accepted resubmitted NDA; Class II review with PDUFA action date June 27, 2026. 03/30/26:- PDUFA date updated to June 29, 2026; commercial readiness and potential Q3 2026 launch preparations ongoing. 05/12/26:- Remain on track for June 29, 2026 PDUFA action date; commercial launch preparations and reimbursement planning continue. 06/30/26:- Received CRL; issues at third-party mfg, inspection pending; labeling ongoing; plans to resubmit NDA. 08/12/26:- FDA assigned third-party vendor facility inspection. NDA will be resubmitted after successful inspection; timing is TBA.