Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027
The FDA accepted Unicycive's resubmission of the NDA for oxylanthanum carbonate and set a PDUFA action date of March 25, 2027 under a Class II six-month review. The resubmission addresses a June 2026 Complete Response Letter — the second CRL — by adding CMC data from a new third-party drug product manufacturer whose facility received 'No Action Indicated' status at its last FDA inspection in March 2024. Key uncertainty remains manufacturing: the company does not know whether the FDA will inspect the new vendor, and any inspection of the original vendor could enable a shorter approval timeline if it passes cGMP review.
Key figures
- Drug Name
- oxylanthanum carbonate (OLC)
- Guidance
- PDUFA target action date of March 25, 2027 (Class II, six-month review)
- Phase Of Trial
- Phase 1 (plus bioequivalence and tolerability studies)
- Pdufa date
- 2027-03-25
- Prior crls
- 2
- Review class
- Class II
- Review period
- six months
- Patent exclusivity
- until 2031, potential extension to 2035
- Us patient population
- 450000
AI analysis
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