Prescription medicine
Cobimetinib Brand names: Cotellic
Cobimetinib (Cotellic) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cobimetinib FDA label on DailyMed (effective July 29, 2026, Genentech, Inc.); the NDA 206192 record on Drugs@FDA; every cobimetinib label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageCOTELLIC ® 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.
Forms and strengths
- 20 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 10, 2015 Cotellic, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 30, 2036 Cotellic tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2017 0 Class I among all firms' recalls; latest March 13, 2017
- FAERS reports
- 4,389 through July 30, 2026
What is cobimetinib used for?
From the label: indications and usageCOTELLIC ® 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. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Cotellic), Genentech, Inc., effective July 29, 2026 (SPL set c387579e-cee0-4334-bd1e-73f93ac1bde6), via openFDA; the full label on DailyMed
What does the patient leaflet for cobimetinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid during treatment with COTELLIC?Avoid sunlight during treatment with COTELLIC. COTELLIC can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn: When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
From the patient leaflet: How should I store COTELLIC?Store COTELLIC at room temperature below 86°F (30°C). Keep COTELLIC and all medicine out of the reach of children.
Source: FDA drug label (Cotellic), Genentech, Inc., effective July 29, 2026 (SPL set c387579e-cee0-4334-bd1e-73f93ac1bde6), via openFDA; the full label on DailyMed
Is there a generic for cobimetinib (Cotellic)?
No generic cobimetinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Cotellic tablets: the compound patent runs to June 30, 2036 (pediatric exclusivity to December 30, 2036). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2036 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cobimetinib been recalled?
The FDA's Enforcement Report lists 1 recall naming cobimetinib since 2017: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2017 | Class II | Genentech Inc. | Superpotent Drug: An oversized tablet was found in a bottle. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cobimetinib label say about other medicines?
The cobimetinib label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name cobimetinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Avoid concurrent use of COTELLIC and strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John's Wort [see Clinical Pharmacology (12.3) ]. |
| Ciprofloxacin | drug interactions | If concurrent short term (14 days or less) use of moderate CYP3A inhibitors including certain antibiotics (e.g., erythromycin, ciprofloxacin) is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20 mg. |
| Efavirenz | drug interactions | Avoid concurrent use of COTELLIC and strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John's Wort [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | If concurrent short term (14 days or less) use of moderate CYP3A inhibitors including certain antibiotics (e.g., erythromycin, ciprofloxacin) is unavoidable for patients who are taking COTELLIC 60 mg, reduce COTELLIC dose to 20 mg. |
| Itraconazole | drug interactions | Strong or Moderate CYP3A Inhibitors on COTELLIC Coadministration of COTELLIC with itraconazole (a strong CYP3A4 inhibitor) increased cobimetinib systemic exposure by 6.7-fold. |
| Phenytoin | drug interactions | Avoid concurrent use of COTELLIC and strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John's Wort [see Clinical Pharmacology (12.3) ]. |
| Rifampin | drug interactions | Avoid concurrent use of COTELLIC and strong or moderate CYP3A inducers including but not limited to carbamazepine, efavirenz, phenytoin, rifampin, and St. John's Wort [see Clinical Pharmacology (12.3) ]. |
| Vemurafenib | warnings and precautions | WARNINGS AND PRECAUTIONS Review the Full Prescribing Information for vemurafenib for information on the serious risks of vemurafenib. |
Other labels that name cobimetinib
Source: FDA drug label (Cotellic), Genentech, Inc., effective July 29, 2026 (SPL set c387579e-cee0-4334-bd1e-73f93ac1bde6), via openFDA; the full label on DailyMed
What do FAERS reports show for cobimetinib?
The FDA Adverse Event Reporting System holds 4,389 reports that list cobimetinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 579 are coded as a death and 2,000 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Cobimetinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other