Propofol · Regulatory approval

FDA approval: Propofol

U.S. Food and Drug Administration · July 14, 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 propofol 10 mg/mL injectable formulation (ANDA 220857) by Anthea Pharma on 14 July 2026. This regulatory action confirms manufacturing and quality standards for market entry but does not report clinical trial results, efficacy data, or comparative benefit evidence.

What was studied

Regulatory approval.

Key findings

Propofol 10 mg/mL injectable formulation approved as ANDA 220857

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence. No information on patient population, dosing regimens, indications, or adverse event profiles is provided in this regulatory action.

Who this may help

This approval permits marketing and distribution of the specified propofol formulation. Clinicians should refer to the approved package insert and established clinical guidelines; this regulatory action does not establish new clinical evidence regarding efficacy or safety.

Plain-language summary

FDA approval of a propofol injectable formulation; regulatory clearance does not establish clinical efficacy or comparative benefit.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-14

Formulation and strengthPROPOFOL, INJECTABLE, INJECTION, PROPOFOL 10MG/ML

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative evidence.
No information on patient population, dosing regimens, indications, or adverse event profiles is provided in this regulatory action.
Approval of an ANDA (Abbreviated New Drug Application) indicates bioequivalence to a reference product but does not report the underlying bioequivalence study or clinical trial data.

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

This is a regulatory action record, not a clinical study.

Directness

insufficient

Record documents approval action only; no clinical trial data presented.

Consistency

insufficient

Single regulatory action; no comparative outcomes or evidence synthesis.

Risk of bias

insufficient

Regulatory approval record; does not report trial methodology or bias assessment.

Sample adequacy

insufficient

No sample size, patient population, or outcome data reported.

Source abstract

Drugs@FDA record for application ANDA220857. This is a regulatory action record, not a clinical study. Brand name: PROPOFOL. Active ingredient: PROPOFOL. Sponsor: ANTHEA PHARMA. Submission type: ORIG (original application). Approval status date: 2026-07-14. Products: PROPOFOL, INJECTABLE, INJECTION, PROPOFOL 10MG/ML.

Follow from this

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

PropofolAnthea Pharma