Quick answers
- What is Lapatinib used for?
- The FDA-approved label (Tykerb, Novartis Pharmaceuticals Corporation, January 27, 2026) says: “TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lapatinib have a boxed warning?
- Yes. The FDA label for Tykerb 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 Lapatinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lapatinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lapatinib?
- 4 companies list prescription products of Lapatinib in the FDA NDC Directory, including Teva Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation and Lupin Pharmaceuticals, Inc..
What Lapatinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use …
— FDA label: Tykerb, Novartis Pharmaceuticals Corporation, effective January 27, 2026. Read the full label on DailyMed →
The FDA has 4 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 →
4 of 4 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 | 4 in the FDA NDC Directory |
| Brand names | Tykerb |
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
- Novartis Pharmaceuticals Corporation1 product
- Lupin Pharmaceuticals, Inc.1 product
- AvKARE1 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 |
|---|---|---|---|
| NDA022059 TYKERB | Novartis | March 13, 2007 | 19, latest March 27, 2022 2022: Labeling · 2018: Labeling · 2018: Efficacy |
Generic approvals (2)
- ANDA203007Natco Pharma Ltd · September 29, 2020
- ANDA217968Teva Pharms USA Inc · August 16, 2024
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) | 672149, 672152 |
|---|---|
| SPL set ID of the quoted label | eee37f88-ec6a-4c30-b8aa-e2c71f93088c |
| FDA labels (SPL) | 4 |
| FDA applications | NDA022059, 2 ANDA |
| Active ingredients (FDA) | LAPATINIB DITOSYLATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tykerb, Novartis Pharmaceuticals Corporation, effective January 27, 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 →