Tasigna

NDA 22068, held by Novartis. Nilotinib Hydrochloride.

As of Nov 14, 2026, NDA 22068 (Tasigna), held by Novartis, was first approved by FDA on Oct 29, 2007, with 33 approved supplements and 0 published complete response letters.

First approved: Oct 29, 2007
Review: Standard
Supplements approved: 33
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age 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. Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Sep 23, 2021	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Sep 23, 2021	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 22, 2018	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 22, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 27, 2015	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 22, 2014	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 20, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 14, 2011	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2010	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 29, 2007	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

3 strengths and forms


TasignaEQ 200MG BASE · capsule;oral	Nilotinib Hydrochloride	RxReference drug
TasignaEQ 150MG BASE · capsule;oral	Nilotinib Hydrochloride	RxReference drug
TasignaEQ 50MG BASE · capsule;oral	Nilotinib Hydrochloride	RxReference drug

All 34 submissions, including labeling and manufacturing supplements


Aug 14, 2024	Supplement 42Labeling · Standard review	Approved	Letter Label
Feb 29, 2024	Supplement 40Manufacturing	Approved	Label Letter
Feb 8, 2024	Supplement 41Labeling · Standard review	Approved	Label Letter
Feb 6, 2024	Supplement 39Manufacturing	Approved	Label
Feb 18, 2022	Supplement 37Manufacturing · Standard review	Approved	Letter Label
Sep 23, 2021	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Sep 23, 2021	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 8, 2020	Supplement 33Labeling · Standard review	Approved	Label Letter
Sep 25, 2019	Supplement 31Labeling · Standard review	Approved	Letter Label
Aug 21, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label
Mar 22, 2018	Supplement 27Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 22, 2017	Supplement 26Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 21, 2017	Supplement 24Labeling · Standard review	Approved	Label Letter
Sep 27, 2016	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 15, 2015	Supplement 21Labeling · Standard review	Approved	Label Letter
Jan 27, 2015	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 25, 2014	Supplement 19Labeling · Standard review	Approved	Label Letter
Jan 22, 2014	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 27, 2013	Supplement 18Labeling	Approved	Letter Label
Aug 14, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 13, 2013	Supplement 14Labeling · Standard review	Approved	Label Letter
May 22, 2013	Supplement 16REMS	Approved	Letter
May 17, 2013	Supplement 13Labeling · Standard review	Approved	Letter
Dec 20, 2012	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 1, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label
Nov 18, 2011	Supplement 9Labeling	Approved	Label Letter
Nov 18, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 26, 2011	Supplement 7Labeling	Approved	Label Letter
Jan 14, 2011	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 17, 2010	Supplement 5Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 17, 2010	Supplement 4Labeling	Approved	Letter Label
Mar 15, 2010	Supplement 1Labeling · Standard review	Approved	Letter Label
Aug 21, 2009	Supplement 2Labeling · Standard review	Approved	Letter Label
Oct 29, 2007	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22068
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals 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