Glycerol Phenylbutyrate · Regulatory approval

FDA approval: Glycerol Phenylbutyrate

U.S. Food and Drug Administration · July 28, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved glycerol phenylbutyrate 1.1 g/mL oral liquid (ANDA 220579, sponsor Esjay Pharma) on 28 July 2026. This is a regulatory action confirming authorization to market; it does not report clinical efficacy, safety data, or comparative trial results.

What was studied

Regulatory approval. Intervention: Glycerol phenylbutyrate 1.1 g/mL oral liquid.

Key findings

Approval date: 28 July 2026 for glycerol phenylbutyrate oral liquid formulation 1.1 g/mL

Safety

This regulatory record does not contain clinical trial results, efficacy data, or safety study findings. Indication, dosage, contraindications, and adverse event profile are not stated in this record.

Who this may help

Regulatory approval permits marketing of the product; clinicians should consult the approved labeling for indication, dosing, contraindications, and safety profile. This approval action alone does not establish clinical superiority or new efficacy evidence.

Plain-language summary

FDA approval of glycerol phenylbutyrate oral liquid formulation; regulatory action confirms marketability but does not report clinical trial outcomes or comparative efficacy.

Study design

As stated by the source record.

InterventionGlycerol phenylbutyrate 1.1 g/mL oral liquid

Reported figures

Quoted from the source exactly as published.

Approval status date2026-07-28

Formulation strength1.1 g/mL

Application typeANDA (Abbreviated New Drug Application)

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety study findings.
No comparator data, control arm, or comparative effectiveness information is reported.
Indication, dosage, contraindications, and adverse event profile are not stated in this record.
The record does not disclose what studies or evidence supported the approval decision.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory record; no clinical study design reported.

Directness

insufficient

Approval record does not report clinical endpoints or patient outcomes.

Consistency

insufficient

No comparative data or evidence synthesis presented in record.

Risk of bias

insufficient

Regulatory approval does not assess study quality or bias.

Sample adequacy

insufficient

No sample size, population, or trial data reported.

Source abstract

Drugs@FDA record for application ANDA220579. This is a regulatory action record, not a clinical study. Brand name: GLYCEROL PHENYLBUTYRATE. Active ingredient: GLYCEROL PHENYLBUTYRATE. Sponsor: ESJAY PHARMA. Submission type: ORIG (original application). Approval status date: 2026-07-28. Products: GLYCEROL PHENYLBUTYRATE, LIQUID, ORAL, GLYCEROL PHENYLBUTYRATE 1.1GM/ML.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Glycerol PhenylbutyrateEsjay Pharma