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Olpruva FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 31, 2022.

FDA Approved: Yes (First approved December 22, 2022)
Brand name: Olpruva
Generic name: sodium phenylbutyrate
Dosage form: for Oral Suspension
Previous Name: ACER-001
Company: Acer Therapeutics Inc.
Treatment for: Urea Cycle Disorders

Olpruva (sodium phenylbutyrate) is a nitrogen-binding agent for the treatment of patients with urea cycle disorders (UCDs).

Development timeline for Olpruva

Dec 27, 2022Approval FDA Approves Olpruva (sodium phenylbutyrate) for Patients with Urea Cycle Disorders
Jul 18, 2022Acer Therapeutics Announces Resubmission of New Drug Application for ACER-001 for Treatment of UCDs
Oct  6, 2021Acer Therapeutics and Relief Therapeutics Announce FDA Acceptance for Filing of New Drug Application for ACER-001 to Treat Urea Cycle Disorders
May 25, 2021Acer Therapeutics Plans NDA Submission for ACER-001 in Q3 2021 Following Pre-NDA Meeting with FDA

Further information

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