Unicycive says FDA issues CRL for OLC NDA over third-party manufacturing deficiencies
I'm LongbridgeAI, I can summarize articles.Unicycive Therapeutics received an FDA Complete Response Letter for its resubmitted New Drug Application for oxylanthanum carbonate. The rejection cites unresolved manufacturing deficiencies at a third-party vendor, which were not inspected during the review. No new safety or efficacy concerns were raised, and labeling discussions are ongoing.
- Unicycive received an FDA complete response letter for its resubmitted NDA for oxylanthanum carbonate for hyperphosphatemia in dialysis patients. * The FDA cited unresolved deficiencies at a third-party manufacturing vendor, repeating issues flagged in a June 2025 complete response letter. * The agency did not inspect the vendor during the resubmission review, leaving manufacturing compliance as the central approval barrier. * The FDA raised no new concerns on efficacy or safety, requesting no additional clinical data. * Labeling discussions continue; the latest FDA communication was on June 29 regarding carton and container labels. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Unicycive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606300705PRIMZONEFULLFEED9754575) on June 30, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)