Quick answers
- What is Sunitinib malate used for?
- The FDA-approved label (Sutent, Pfizer Laboratories Div Pfizer Inc, February 20, 2026) says: “SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • treatment of adult patients with advanced renal cell carcinoma (RCC). • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sunitinib malate have a boxed warning?
- Yes. The FDA label for Sutent has a boxed warning (“WARNING: HEPATOTOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sunitinib malate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sunitinib malate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started October 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Sunitinib malate?
- 9 companies list prescription products of Sunitinib malate in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc., Aurobindo Pharma Limited and Novugen Pharma (USA) LLC.
What Sunitinib malate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • treatment of adult patients with advanced renal cell carcinoma (RCC). • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. …
— FDA label: Sutent, Pfizer Laboratories Div Pfizer Inc, effective February 20, 2026. Read the full label on DailyMed →
The FDA has 9 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. Its heading: WARNING: HEPATOTOXICITY
. Read it on the full label →
9 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Sutent |
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.
- Teva Pharmaceuticals USA, Inc.4 products
- Aurobindo Pharma Limited4 products
- Novugen Pharma (USA) LLC4 products
- Dr.Reddys Laboratories Inc4 products
- Pfizer Laboratories Div Pfizer Inc4 products
- Mylan Pharmaceuticals Inc.4 products
- Novadoz Pharmaceuticals LLC4 products
- AvKARE4 products
- Sun Pharmaceutical Industries, Inc.4 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 |
|---|---|---|---|
| NDA021938 SUTENT | Cppi Cv | January 26, 2006 | 35, latest August 30, 2021 2021: Efficacy · 2020: Labeling · 2020: Labeling |
Generic approvals (7)
- ANDA213914Sun Pharm · August 16, 2021
- ANDA213803Teva Pharms USA · November 30, 2021
- ANDA201275Mylan · December 6, 2021
- ANDA215843DR Reddys · April 11, 2022
- ANDA218012Fosun Wanbang · August 21, 2023
- ANDA218615Eugia Pharma · March 14, 2024
- ANDA214824Msn · February 14, 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.
-
October 18, 2024 · Class II · Ongoing · D-0104-2025
Labeling: Label Mix-Up
Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 — AvKARE
-
October 18, 2024 · Class II · Ongoing · D-0103-2025
Labeling: Label Mix-Up
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28 — AvKARE
-
July 5, 2023 · Class II · Terminated · D-0913-2023
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 — Teva Pharmaceuticals 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) — Sutent, Pfizer Laboratories Div Pfizer Inc, effective February 20, 2026; 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 →