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Pheburane® (sodium phenylbutyrate) – New orphan drug approval

June 17, 2022 - The FDA approved Medunik’s Pheburane (sodium phenylbutyrate) oral pellets, as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients with urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS).

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