USFDAJun 30, 2026, 07:06 AM
Unicycive Receives FDA CRL for OLC NDA Due to Manufacturing Deficiencies
AI Summary
Unicycive Therapeutics announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for oxylanthanum carbonate (OLC). The CRL cited deficiencies at a third-party manufacturing vendor, which were previously identified in a June 2025 CRL. The FDA did not raise concerns about OLC's clinical efficacy or safety data and did not request additional data, with labeling discussions currently in progress.
Key Highlights
- Unicycive received a Complete Response Letter (CRL) from the FDA for OLC NDA.
- CRL is due to deficiencies at a third-party manufacturing vendor, identified in a previous CRL.
- FDA did not inspect the third-party manufacturing facility during the resubmission review.
- FDA raised no concerns regarding OLC's clinical efficacy or safety data.
- No additional clinical data was requested by the FDA.
- Labeling discussions for OLC are currently underway with the FDA.
- Company remains confident in OLC's efficacy and safety and plans to resubmit NDA.
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