Quick answers
- What is Cobimetinib used for?
- The FDA-approved label (Cotellic, Genentech, Inc., July 29, 2026) says: “COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1, 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Cobimetinib have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Cobimetinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Cobimetinib been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 13, 2017 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Cobimetinib?
- 1 company lists prescription products of Cobimetinib in the FDA NDC Directory, including Genentech, Inc..
What Cobimetinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1, 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. …
— FDA label: Cotellic, Genentech, Inc., effective July 29, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Cotellic |
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.
- Genentech, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206192 COTELLIC | Genentech Inc | November 10, 2015 | 6, latest August 20, 2026 2026: Labeling · 2023: Labeling · 2022: Efficacy |
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.
-
March 13, 2017 · Class II · Terminated · D-0648-2017
Superpotent Drug: An oversized tablet was found in a bottle.
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco, CA. 94080, NDC 50242-717-01,UPC 3 50242-717-01. — Genentech 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
| RxCUI (RxNorm) | 1722370, 1722376 |
|---|---|
| SPL set ID of the quoted label | c387579e-cee0-4334-bd1e-73f93ac1bde6 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206192 |
| Active ingredients (FDA) | COBIMETINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cotellic, Genentech, Inc., effective July 29, 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 →