Quick answers
- What is Pazopanib used for?
- The FDA-approved label (Votrient, Novartis Pharmaceuticals Corporation, December 16, 2025) says: “VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pazopanib have a boxed warning?
- Yes. The FDA label for Votrient 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 Pazopanib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pazopanib been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 20, 2023 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Pazopanib?
- 9 companies list prescription products of Pazopanib in the FDA NDC Directory, including Teva Pharmaceuticals, Inc., Aurobindo Pharma Limited and Novugen Pharma (USA) LLC.
What Pazopanib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. …
— FDA label: Votrient, 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. Its heading: WARNING: HEPATOTOXICITY
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Votrient |
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, Inc.1 product
- Aurobindo Pharma Limited1 product
- Novugen Pharma (USA) LLC1 product
- Novartis Pharmaceuticals Corporation1 product
- Torrent Pharmaceuticals Limited1 product
- AvKARE1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Apotex Corp.1 product
- Golden State Medical Supply, Inc.1 product
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 |
|---|---|---|---|
| NDA022465 VOTRIENT | Novartis | October 19, 2009 | 28, latest January 25, 2024 2024: Labeling · 2021: Manufacturing (CMC) · 2021: Labeling |
Generic approvals (6)
- ANDA215837Sun Pharm · October 19, 2023
- ANDA217517Teva Pharms Inc · October 19, 2023
- ANDA217713Apotex · October 19, 2023
- ANDA218231Novugen · April 23, 2024
- ANDA219034Eugia Pharma · December 4, 2024
- ANDA219922Torrent · September 4, 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.
-
November 20, 2023 · Class III · Completed · D-0149-2024
Failed Dissolution Specifications
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077- — Siegfried Barbera, SL
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
| RxCUI (RxNorm) | 867502, 867506, 867508 |
|---|---|
| SPL set ID of the quoted label | eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA022465, 6 ANDA |
| Active ingredients (FDA) | PAZOPANIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Votrient, 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 →