Shilpa Medicare has announced that the USFDA has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) filed by Unicycive for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis.
You might also like
Currently, CKD patients often take up to 12 pills daily to manage hyperphosphatemia. OLC offers a promising solution with fewer pills and easy-to-swallow tablets, improving patient adherence and treatment outcomes.
Unicycive has entered into a long-term manufacturing arrangement with Shilpa to deliver the product on a commercial scale once approved by the USFDA. Unicycive’s NDA is now being reviewed and it is planned to commercialize and launch OLC in the US market in the second half of calendar year 2025.
