Olpruva™ (sodium phenylbutyrate) – New drug approval
December 27, 2022 - Acer Therapeutics and Relief Therapeutics announced the FDA approval of Olpruva (sodium phenylbutyrate) oral suspension, as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients weighing 20 kg or greater and with a body surface area of 1.2 m2 or greater, with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
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