Tofacitinib · Regulatory approval

FDA approval: Tofacitinib

U.S. Food and Drug Administration · June 3, 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 an original ANDA application for generic tofacitinib citrate tablets (5 mg and 10 mg base equivalents) by sponsor Apotex on 3 June 2026. This is a regulatory approval action and does not contain clinical trial results, efficacy data, or comparative safety information.

What was studied

Regulatory approval.

Key findings

Approved formulations: tofacitinib citrate 5 mg and 10 mg tablets, oral Sponsor: Apotex Approval date: 3 June 2026

Safety

This is a regulatory approval record; no clinical trial results, efficacy endpoints, or safety data are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a generic tofacitinib formulation; regulatory action does not convey clinical trial evidence or comparative efficacy.

Reported figures

Quoted from the source exactly as published.

Approved strengths5 mg, 10 mg

Approval date2026-06-03

Caveats

This is a regulatory approval record; no clinical trial results, efficacy endpoints, or safety data are reported.
No information on indication(s), comparative effectiveness, or post-market surveillance is provided.
The record does not specify the original reference product, bioequivalence study, or approval rationale.
No sample size, dosing regimen, or patient population details are included.

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 trial design reported.

Directness

insufficient

Approval record does not report clinical outcomes or comparators.

Consistency

insufficient

Single regulatory action; no comparative data presented.

Risk of bias

insufficient

Regulatory record; methodological quality not assessed.

Sample adequacy

insufficient

No sample size or trial population reported.

Source abstract

Drugs@FDA record for application ANDA218096. This is a regulatory action record, not a clinical study. Brand name: TOFACITINIB. Active ingredient: TOFACITINIB. Sponsor: APOTEX. Submission type: ORIG (original application). Approval status date: 2026-06-03. Products: TOFACITINIB CITRATE, TABLET, ORAL, TOFACITINIB CITRATE EQ 10MG BASE; TOFACITINIB CITRATE, TABLET, ORAL, TOFACITINIB CITRATE EQ 5MG BASE.

Follow from this

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

TofacitinibApotex