Olpruva

NDA 214860, held by Acer. Sodium Phenylbutyrate.

As of Nov 13, 2026, NDA 214860 (Olpruva), held by Acer, was first approved by FDA on Dec 22, 2022, with 1 approved supplement and 1 published complete response letter.

• First approved: Dec 22, 2022
• Review: Standard
• Supplements approved: 1
• Complete response letters: 1

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters