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McCoubrey LE, Favaron A, Awad A, Orlu M, Gaisford S, Basit AW (2023) Colonic drug delivery, Formulating the next generation of colon-targeted therapeutics

The FDAs approval, which is for both subcutaneous and intravenous formulations of Otulfi, was backed by a thorough evaluation of a comprehensive data package, which included analytical, preclinical, clinical and manufacturing data, according to the companies