FDA — authorised 7 November 1996
- Application: NDA020573
- Marketing authorisation holder: HORIZON THERAP US
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 SODIUM PHENYLBUTYRATE in United States
FDA authorised SODIUM PHENYLBUTYRATE on 7 November 1996 · 151 US adverse-event reports
Marketing authorisations
FDA — authorised 7 November 1996
- Application: NDA020572
- Marketing authorisation holder: HORIZON THERAP US
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 November 2011
- Application: ANDA090910
- Marketing authorisation holder: ALVOGEN
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2013
- Application: ANDA202819
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 15 April 2016
- Application: ANDA204395
- Marketing authorisation holder: PH HEALTH
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2016
- Application: ANDA203918
- Marketing authorisation holder: PH HEALTH
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: POWDER — ORAL
- Status: approved
FDA — authorised 1 November 2022
- Application: ANDA216462
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2022
- Application: NDA214860
- Marketing authorisation holder: ACER
- Local brand name: OLPRUVA
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 February 2026
- Application: ANDA220418
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: SODIUM PHENYLBUTYRATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 151
Most-reported reactions
- Diarrhoea — 26 reports (17.22%)
- Death — 24 reports (15.89%)
- Off Label Use — 21 reports (13.91%)
- Hyperammonaemia — 14 reports (9.27%)
- Nausea — 14 reports (9.27%)
- Decreased Appetite — 12 reports (7.95%)
- Drug Ineffective — 11 reports (7.28%)
- Fatigue — 11 reports (7.28%)
- Abdominal Pain — 9 reports (5.96%)
- Dyspnoea — 9 reports (5.96%)
SODIUM PHENYLBUTYRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SODIUM PHENYLBUTYRATE approved in United States?
Yes. FDA authorised it on 7 November 1996; FDA authorised it on 7 November 1996; FDA authorised it on 18 November 2011.
Who is the marketing authorisation holder for SODIUM PHENYLBUTYRATE in United States?
HORIZON THERAP US holds the US marketing authorisation.