Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-05 05:50 GMT | Update On 2024-09-05 05:50 GMT
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Karnataka: Unicycive Therapeutics, Inc. has announced the submission of New Drug Application (NDA) to United States Food and Drug Application (U.S. FDA) for Oxylanthanum Carbonate for Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease(CKD) on Dialysis.
The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).
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