Xeljanz

NDA 203214, held by Pf Prism Cv. Tofacitinib Citrate.

As of Nov 14, 2026, NDA 203214 (Xeljanz), held by Pf Prism Cv, was first approved by FDA on Nov 6, 2012, with 29 approved supplements and 0 published complete response letters.

First approved: Nov 6, 2012
Review: Standard
Supplements approved: 29
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with:

Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Mar 6, 2026	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 16, 2025	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 21, 2025	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 14, 2021	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 25, 2020	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 30, 2018	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 14, 2017	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 22, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label
Feb 21, 2014	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 18, 2013	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 6, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


XeljanzEQ 5MG BASE · tablet;oral	Tofacitinib Citrate	RxReference drug
XeljanzEQ 10MG BASE · tablet;oral	Tofacitinib Citrate	RxReference drug

All 30 submissions, including labeling and manufacturing supplements


Sep 16, 2026	Supplement 42Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 30, 2026	Supplement 43Labeling · Standard review	Approved	Label Letter
Mar 6, 2026	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 16, 2025	Supplement 39Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 21, 2025	Supplement 38Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 27, 2024	Supplement 36Labeling · Standard review	Approved	Label Letter
May 14, 2024	Supplement 34Labeling · Standard review	Approved	Letter Label
Dec 14, 2021	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2021	Supplement 31Labeling · Standard review	Approved	Letter Label
Sep 25, 2020	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 12, 2019	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 30, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 25, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 18, 2018	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 17, 2018	Supplement 21Labeling · Standard review	Approved	Label Letter
May 30, 2018	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 14, 2017	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 22, 2017	Supplement 16Labeling · Standard review	Approved	Label
Aug 22, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label
Feb 8, 2016	Supplement 13REMS	Approved	Review Letter
Dec 22, 2015	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 19, 2015	Supplement 10Labeling · Standard review	Approved	Letter Label
Feb 11, 2015	Supplement 8REMS	Approved	Review Letter
May 7, 2014	Supplement 7Labeling · Standard review	Approved	Label Letter
Mar 26, 2014	Supplement 5Labeling · Standard review	Approved	Label Letter
Feb 21, 2014	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 18, 2013	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 8, 2013	Supplement 6REMS	Approved	Letter
May 3, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 6, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 203214
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters