← FDA DRUG APPROVALS

FDA NDA · NDA217180

JAKAFI XR

Sponsor: INCYTE CORP

APPLICATION
NDA217180
TYPE
NDA
ORIGINAL APPROVAL
2026-05-01
LATEST ACTION
2026-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

JAKAFI XR · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 44MG BASE · TABLET, EXTENDED RELEASE · ORAL
JAKAFI XR · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 22MG BASE · TABLET, EXTENDED RELEASE · ORAL
JAKAFI XR · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 55MG BASE · TABLET, EXTENDED RELEASE · ORAL
JAKAFI XR · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 33MG BASE · TABLET, EXTENDED RELEASE · ORAL
JAKAFI XR · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 11MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-20Labeling · Supplement 1 · standard — Letter ↗AP
2026-05-01Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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