Oxylanthanum carbonate fda review approval

The FDA review approval process for Oxylanthanum Carbonate (OLC) is ongoing. Here is a summary of the key events related to the FDA review approval process for OLC:

1. **NDA Submission**: On September 3, 2024, Unicycive Therapeutics submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OLC for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
2. **FDA Alignment**: Prior to the NDA submission, Unicycive Therapeutics reached alignment with the FDA on the path forward for OLC and the overall package requirements to file a New Drug Application. This alignment included agreement on the data package, which included clinical data, preclinical data, and Chemistry, Manufacturing, and Controls (CMC) data.
3. **Type C Meeting**: During a Type C meeting with the FDA, Unicycive Therapeutics confirmed the pivotal clinical trial design, which will evaluate the tolerability and event rate for discontinuation of OLC in CKD patients on dialysis. The trial is expected to initiate before the end of the year.
4. **PDUFA Waiver**: The FDA granted a waiver for the NDA application Prescription Drug User Fee Act (PDUFA) fees, resulting in a significant savings of approximately $4 million for Unicycive Therapeutics.
5. **Review Process**: Once the NDA is reviewed by the FDA, the agency will assess the data provided by Unicycive Therapeutics to determine if OLC meets the standards for safety and efficacy. If the FDA approves OLC, it will share substantially the same product label and prescribing information as the reference-listed drug Fosrenol (lanthanum carbonate), with the exception of OLC's smaller tablet size and the method of administration.
6. **Approval Timeline**: It is not currently clear when the FDA will make a decision on the NDA for OLC. The review process can take several months to complete, and the FDA may request additional information or clinical trials if needed.

In summary, the FDA review approval process for Oxylanthanum Carbonate is ongoing, with the NDA having been submitted on September 3, 2024. Unicycive Therapeutics has reached alignment with the FDA and confirmed the design of the pivotal clinical trial. The FDA granted a waiver for the PDUFA fees, and if approved, OLC will share a similar product label with Fosrenol but with distinct differences in tablet size and administration method. The approval timeline is not yet clear, as it depends on the FDA's review process and any potential requests for additional information or clinical trials.