Jakafi

Treats intermediate or high-risk myelofibrosis (MF), including primary MF…. NDA 202192, held by Incyte Corp. Ruxolitinib Phosphate.

As of Nov 13, 2026, NDA 202192 (Jakafi), held by Incyte Corp, was first approved by FDA on Nov 16, 2011, with 21 approved supplements and 0 published complete response letters.

First approved: Nov 16, 2011
Review: Priority
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Dec 19, 2022	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 22, 2021	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 24, 2019	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 10, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Review Letter Label
Mar 10, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 4, 2014	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 25, 2014	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 12, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 16, 2011	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Products

5 strengths and forms

Product	Active ingredient	Marketing
JakafiEQ 5MG BASE · tablet;oral	Ruxolitinib Phosphate	RxReference drug
JakafiEQ 10MG BASE · tablet;oral	Ruxolitinib Phosphate	RxReference drug
JakafiEQ 15MG BASE · tablet;oral	Ruxolitinib Phosphate	RxReference drug
JakafiEQ 20MG BASE · tablet;oral	Ruxolitinib Phosphate	RxReference drug
JakafiEQ 25MG BASE · tablet;oral	Ruxolitinib Phosphate	RxReference drug

All 22 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 20, 2026	Supplement 33Labeling · Standard review	Approved	Label Letter
Jan 31, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
Dec 19, 2022	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter
Sep 27, 2021	Supplement 25Labeling · Standard review	Approved	Label Letter
Sep 22, 2021	Supplement 23Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 14, 2020	Supplement 19Labeling · Standard review	Approved	Label Letter
May 24, 2019	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Oct 26, 2018	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 6, 2017	Supplement 15Labeling · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Oct 10, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Review Review Letter Label
Mar 10, 2016	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 2, 2015	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 6, 2015	Supplement 11Manufacturing · Priority review	Approved	None posted
Dec 15, 2014	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 4, 2014	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 25, 2014	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 30, 2014	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 25, 2013	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 7, 2013	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 12, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 21, 2012	Supplement 1Labeling · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Nov 16, 2011	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 202192
Drugs@FDA: Overview at FDA
Company: Incyte Corporation

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