Danziten

Treats newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+…. NDA 219293, held by Azurity. Nilotinib Tartrate.

As of Nov 13, 2026, NDA 219293 (Danziten), held by Azurity, was first approved by FDA on Nov 7, 2024, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 7, 2024
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DANZITEN is a kinase inhibitor indicated for the treatment of:

Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. 1.1 Adult Patients with Newly Diagnosed Ph+ CML-CP DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna (nilotinib) capsules.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 7, 2024	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

2 strengths and forms

Product	Active ingredient	Marketing
DanzitenEQ 71MG BASE · tablet;oral	Nilotinib Tartrate	RxReference drug
DanzitenEQ 95MG BASE · tablet;oral	Nilotinib Tartrate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 14, 2026	Supplement 6Labeling · Standard review	Approved	Medication Guide Label Letter
Nov 14, 2025	Supplement 5Labeling · Standard review	Approved	Letter Label
Nov 7, 2024	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: DANZITENSep 9, 2025

Identifiers

Application: NDA 219293
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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