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# FDA Approves Acer’s Olpruva for Urea Cycle Disorders
- URL: https://www.fdaweb.com/fda-approves-acers-olpruva-for-urea-cycle-disorders/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153465

FDA has approved Acer Therapeutics’ NDA for Olpruva (sodium phenylbutyrate) to treat patients with urea cycle disorders. The approval [letter](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214860&ref=fdaweb.com) says Olpruva for oral suspension is approved as adjunctive therapy to standard of care, including dietary management, for the chronic management of some adult and pediatric patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.

Acer resubmitted its NDA in 7/2022 after receiving a 6/2022 complete response letter from FDA.