Tofacitinib · Regulatory approval

FDA approval: Tofacitinib

U.S. Food and Drug Administration · June 9, 2026

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AI Summary

This is an FDA approval of a generic extended-release tofacitinib formulation (11 mg base) submitted by Orient Pharma, approved 9 June 2026. The record documents regulatory action only and does not contain clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory approval. Intervention: TOFACITINIB CITRATE, extended-release tablet, 11 mg base.

Key findings

FDA approved TOFACITINIB CITRATE extended-release 11 mg tablet formulation on 2026-06-09

Safety

This record documents regulatory approval only and does not contain clinical trial results, efficacy outcomes, or safety data

Who this may help

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

Plain-language summary

FDA approval of a generic extended-release tofacitinib formulation; this is a regulatory action record without clinical trial data or comparative efficacy evidence.

Study design

As stated by the source record.

InterventionTOFACITINIB CITRATE, extended-release tablet, 11 mg base

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-09

Dose strength11 mg base

Caveats

This record documents regulatory approval only and does not contain clinical trial results, efficacy outcomes, or safety data
No comparative benefit or bioequivalence data are reported in this approval record
Approval as a generic formulation indicates prior demonstration of bioequivalence to reference product, but such data are not provided 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

This is a regulatory record, not a clinical study.

Directness

insufficient

No clinical endpoints or outcome data reported in this approval record.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Regulatory approval record does not include trial methodology or bias assessment.

Sample adequacy

insufficient

No human study sample or trial participants reported in this approval.

Source abstract

Drugs@FDA record for application ANDA219830. This is a regulatory action record, not a clinical study. Brand name: TOFACITINIB. Active ingredient: TOFACITINIB. Sponsor: ORIENT PHARMA. Submission type: ORIG (original application). Approval status date: 2026-06-09. Products: TOFACITINIB CITRATE, TABLET, EXTENDED RELEASE, ORAL, TOFACITINIB CITRATE EQ 11MG BASE.

Follow from this

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

Orient PharmaTofacitinib