Quick answers
- What is Nilotinib used for?
- The FDA-approved label (Tasigna, Novartis Pharmaceuticals Corporation, December 16, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nilotinib have a boxed warning?
- Yes. The FDA label for Tasigna has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Nilotinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nilotinib been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 18, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Nilotinib?
- 10 companies list prescription products of Nilotinib in the FDA NDC Directory, including Apotex Corp., Novadoz Pharmaceuticals LLC and Cipla USA Inc..
What Nilotinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Tasigna, Novartis Pharmaceuticals Corporation, effective December 16, 2025. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Apotex Corp.3 products
- Novadoz Pharmaceuticals LLC3 products
- Cipla USA Inc.3 products
- Dr. Reddy's Laboratories Inc.3 products
- Novartis Pharmaceuticals Corporation3 products
- Azurity Pharmaceuticals, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Cycle Pharmaceuticals Ltd2 products
- AvKARE2 products
- Torrent Pharmaceuticals Limited2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022068 TASIGNA | Novartis | October 29, 2007 | 33, latest August 14, 2024 2024: Labeling · 2024: Manufacturing (CMC) · 2024: Labeling |
| NDA217379 CAVHANZA | Cycle | May 29, 2026 | 1, latest July 29, 2026 2026: Labeling |
| NDA218922 NILOTINIB D-TARTRATE | Cipla | February 19, 2025 | 1, latest July 10, 2025 2025: Labeling |
| NDA219293 DANZITEN | Azurity | November 7, 2024 | 2, latest April 14, 2026 2026: Labeling · 2025: Labeling |
Generic approvals (5)
- ANDA203640Apotex · January 5, 2024
- ANDA209651Hetero Labs Ltd V · November 19, 2025
- ANDA218350DR Reddys · November 19, 2025
- ANDA218544Msn · November 19, 2025
- ANDA218532Torrent · December 15, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 18, 2026 · Class III · Ongoing · D-0382-2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 2 — Cipla USA, Inc.
-
February 18, 2026 · Class III · Ongoing · D-0381-2026
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carto — Cipla USA, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tasigna, Novartis Pharmaceuticals Corporation, effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →