Tofacitinib Citrate · Regulatory approval

FDA approval: Tofacitinib Citrate

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

This is a regulatory record documenting FDA approval of generic tofacitinib citrate tablets (5 mg and 10 mg) by SPECGX LLC, effective 2026-06-03. The record confirms marketing authorization but does not contain clinical trial results, efficacy data, or comparative effectiveness evidence.

What was studied

Regulatory approval.

Key findings

FDA approval granted for tofacitinib citrate 5 mg tablet formulation FDA approval granted for tofacitinib citrate 10 mg tablet formulation

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes.

Who this may help

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

Plain-language summary

FDA approval action for a generic tofacitinib citrate formulation; does not report clinical trial outcomes or comparative efficacy data.

Reported figures

Quoted from the source exactly as published.

Approval status date2026-06-03

Approved strength 15 mg base

Approved strength 210 mg base

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparative effectiveness or bioequivalence data reported in this regulatory record.
Record does not specify indication(s) for use or clinical context of approval.
Generic approval (ANDA) typically relies on bioequivalence to reference product; such data not detailed here.

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 approval record; no clinical study design reported.

Directness

insufficient

Record does not report clinical endpoints or patient outcomes.

Consistency

insufficient

No comparative efficacy data or consistency assessment provided.

Risk of bias

insufficient

Regulatory approval record; risk of bias assessment not applicable.

Sample adequacy

insufficient

No clinical sample or trial population described in record.

Source abstract

Drugs@FDA record for application ANDA219395. This is a regulatory action record, not a clinical study. Brand name: TOFACITINIB CITRATE. Active ingredient: TOFACITINIB CITRATE. Sponsor: SPECGX LLC. Submission type: ORIG (original application). Approval status date: 2026-06-03. Products: TOFACITINIB CITRATE, TABLET, ORAL, TOFACITINIB CITRATE EQ 5MG BASE; TOFACITINIB CITRATE, TABLET, ORAL, TOFACITINIB CITRATE EQ 10MG BASE.

Follow from this

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

SpecgxTofacitinib Citrate