Quick answers
- What is Sorafenib used for?
- The FDA-approved label (Nexavar, Bayer HealthCare Pharmaceuticals Inc., August 28, 2023) says: “NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma • Advanced renal cell carcinoma • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sorafenib have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sorafenib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sorafenib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sorafenib?
- 8 companies list prescription products of Sorafenib in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc., Yabao Pharmaceutical Co., Ltd. Beijing and Torrent Pharmaceuticals Limited.
What Sorafenib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma • Advanced renal cell carcinoma • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment 1.1 Hepatocellular Carcinoma NEXAVAR ® is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). …
— FDA label: Nexavar, Bayer HealthCare Pharmaceuticals Inc., effective August 28, 2023. 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.
The label quoted above has no boxed warning.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Nexavar |
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.
- Bayer HealthCare Pharmaceuticals Inc.2 products
- Yabao Pharmaceutical Co., Ltd. Beijing1 product
- Torrent Pharmaceuticals Limited1 product
- Golden State Medical Supply, Inc.1 product
- Upsher-Smith Laboratories, LLC1 product
- Dr.Reddys Laboratories Inc1 product
- Teva Pharmaceuticals, Inc.1 product
- Mylan Pharmaceuticals 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 |
|---|---|---|---|
| NDA021923 NEXAVAR | Bayer Hlthcare | December 1, 2005 | 22, latest August 28, 2023 2023: Manufacturing (CMC) · 2021: Labeling · 2020: Labeling |
Generic approvals (5)
- ANDA207012Mylan · September 10, 2020
- ANDA209567Teva Pharms USA Inc · November 12, 2020
- ANDA216073DR Reddys · June 7, 2022
- ANDA209050Yabao Pharm · November 9, 2022
- ANDA217095Torrent · April 12, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 597747, 615979 |
|---|---|
| SPL set ID of the quoted label | b50667e4-5ebc-4968-a646-d605058dbef0 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA021923, 5 ANDA |
| Active ingredients (FDA) | SORAFENIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nexavar, Bayer HealthCare Pharmaceuticals Inc., effective August 28, 2023; 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 →