Drug or technology

Tofacitinib

4 developments in the corpus

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JUN 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Xeljanz (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling change to tofacitinib (Xeljanz); regulatory action only, no clinical trial data reported.

Regulatory UpdateTofacitinib PF Prism CV

JUN 30, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Xeljanz XR (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval of labeling for Xeljanz XR (tofacitinib); regulatory action does not report clinical trial efficacy or safety data.

Regulatory UpdateTofacitinib Pfizer

Reported

Approval date2026-06-30

Active ingredient strength 1TOFACITINIB CITRATE EQ 11MG BASE

Active ingredient strength 2TOFACITINIB CITRATE EQ 22MG BASE

JUN 9, 2026 · REGULATORY APPROVAL

FDA approval: Tofacitinib

U.S. Food and Drug Administration

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

Insufficient InformationOrient Pharma Tofacitinib

Reported

Approval date2026-06-09

Dose strength11 mg base

JUN 3, 2026 · REGULATORY APPROVAL

FDA approval: Tofacitinib

U.S. Food and Drug Administration

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

Regulatory UpdateTofacitinib Apotex

Reported

Approved strengths5 mg, 10 mg

Approval date2026-06-03