Argatroban · Regulatory label update

FDA supplemental approval: Argatroban (Labeling)

U.S. Food and Drug Administration · May 15, 2026

Regulatory Update Why this matters to you Expert discussion

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

AI Summary

This is a U.S. FDA supplemental approval action for labeling changes to argatroban injectable formulations. The record documents a regulatory filing and approval date but does not contain clinical trial results, efficacy data, or safety outcomes.

What was studied

Regulatory label update.

Key findings

Supplemental labeling approval granted for argatroban 50 mg/50 mL (1 mg/mL) and 250 mg/2.5 mL (100 mg/mL) injectable formulations Approval date: 2026-05-15 Sponsor: HIKMA PHARM CO LTD

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. Sponsor: HIKMA PHARM CO LTD

Who this may help

This regulatory record documents an administrative approval action. Clinicians should consult the updated prescribing information for any changes to dosing, indications, contraindications, or safety warnings; this record does not itself describe what labeling changes were made.

Plain-language summary

FDA supplemental approval for labeling changes to argatroban; regulatory action without new clinical trial data or efficacy claims.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-05-15

Formulation 1ARGATROBAN 50MG/50ML (1MG/ML)

Formulation 2ARGATROBAN 250MG/2.5ML (100MG/ML)

Clinical bottom line

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
The specific content of the labeling changes is not disclosed in this regulatory filing record.
No comparative data, sample size, or statistical measures are provided.
This is an approval action only; the rationale and supporting evidence are not included in this record.

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 labeling record; no clinical study design reported.

Directness

insufficient

No clinical outcomes or comparators specified in this regulatory filing.

Consistency

insufficient

Single regulatory action; no comparative data or replication reported.

Risk of bias

insufficient

Regulatory approval record; bias assessment not applicable to labeling submission.

Sample adequacy

insufficient

No patient sample or trial population described in this record.

Source abstract

Drugs@FDA record for application NDA203049. This is a regulatory action record, not a clinical study. Brand name: ARGATROBAN. Active ingredient: ARGATROBAN. Sponsor: HIKMA PHARM CO LTD. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-15. Products: ARGATROBAN, INJECTABLE, INJECTION, ARGATROBAN 50MG/50ML (1MG/ML); ARGATROBAN, INJECTABLE, INJECTION, ARGATROBAN 250MG/2.5ML (100MG/ML).

Follow from this

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

Hikma Pharm COArgatroban