Oxylanthanum Carbonate PDUFA date: FDA decision expected March 25, 2027
The FDA is expected to decide on Oxylanthanum Carbonate from Unicycive Therapeutics, Inc. in Chronic Kidney Disease Requiring Chronic Dialysis by the PDUFA target action date of March 25, 2027. Extracted from news: Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resub
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: drugs.com · Data checked October 22, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Oxylanthanum Carbonate?
- The FDA's PDUFA target action date for Oxylanthanum Carbonate is March 25, 2027. The FDA can act before that date, and the review can be extended.
- What is Oxylanthanum Carbonate being reviewed for?
- The application under FDA review covers Chronic Kidney Disease Requiring Chronic Dialysis.
- Which company is developing Oxylanthanum Carbonate?
- Unicycive Therapeutics, Inc. (UNCY).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).