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# FDA Oxylanthanum Carbonate Complete Response Letter
- URL: https://www.fdaweb.com/fda-oxylanthanum-carbonate-complete-response-letter/
- Published: 2025-07-07T12:00:00.000Z
- Updated: 2026-09-14T15:15:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159437

FDA has issued a complete response letter (CRL) to Unicycive Therapeutics for its NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in dialysis patients with chronic kidney disease. A company [statement](https://ir.unicycive.com/news/detail/104/unicycive-therapeutics-announces-receipt-of-complete?ref=fdaweb.com) says the letter cited deficiencies previously identified at a third-party manufacturing vendor unrelated to OLC. There were no other concerns stated in the CRL, it says.

Unicycive says it has identified a second manufacturing vendor that has already produced an OLC drug product and could be used to support the resolution of the clinical, manufacturing, and controls issues identified in the letter. It will seek a meeting with the agency to discuss the next steps, the company says.