Prescription medicine
Selumetinib Brand names: Koselugo
Selumetinib (Koselugo) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the selumetinib FDA label on DailyMed (effective May 26, 2026, AstraZeneca Pharmaceuticals LP); the NDA 213756 record on Drugs@FDA; every selumetinib label on DailyMed.
Highlights of the record
FDA label of May 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ].
Forms and strengths
- 5 mg
- 7.5 mg
- 10 mg
- 25 mg
Capsule; granule.
On the market
- Earliest approval on file
- April 10, 2020 Koselugo, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 26, 2029 Koselugo capsules; 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)
- No recall recorded
- FAERS reports
- 1,530 through July 30, 2026
What is selumetinib used for?
From the label: indications and usageKOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (KOSELUGO), AstraZeneca Pharmaceuticals LP, effective May 26, 2026 (SPL set 7d042c61-f28f-4ab5-ab10-d7558c0d49ff), via openFDA; the full label on DailyMed
What does the patient leaflet for selumetinib 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 while taking KOSELUGO?Avoid St John’s wort, grapefruit or grapefruit juice, and Seville orange during treatment with KOSELUGO.
From the patient leaflet: How should I store KOSELUGO?Store KOSELUGO capsules and KOSELUGO oral granules at room temperature between 68°F to 77°F (20°C to 25°C). • Do not store KOSELUGO oral granules above 86°F (30°C). Store KOSELUGO oral granules in the refrigerator between 36°F to 46°F (2°C to 8°C) if the temperature is above 86°F (30°C). KOSELUGO oral granules may clump together or stick to the capsule shell if the medicine gets too hot, and you may not get your full dose. • Keep KOSELUGO oral granules cold in a cooler bag with a cold pack if you need to take it anywhere. • The bottle of KOSELUGO capsules and KOSELUGO oral granules contain a desiccant packet to reduce moisture. Do not throw away the desiccant packet. • Keep KOSELUGO capsules and KOSELUGO oral granules in its original bottle to protect from light and moisture. Keep the bottle tightly closed. Keep KOSELUGO and all medicines out of the reach of children.
Source: FDA drug label (KOSELUGO), AstraZeneca Pharmaceuticals LP, effective May 26, 2026 (SPL set 7d042c61-f28f-4ab5-ab10-d7558c0d49ff), via openFDA; the full label on DailyMed
Is there a generic for selumetinib (Koselugo)?
No generic selumetinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Koselugo capsules: the compound patent runs to March 13, 2028, and the last listed entry to March 26, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the selumetinib label say about other medicines?
The selumetinib label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Fluconazole | drug interactions | Strong or Moderate CYP3A4 Inhibitors or Fluconazole: Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO. |
| Loperamide | warnings and precautions | Gastrointestinal Toxicity: Advise patients to start an anti-diarrheal agent immediately after the first episode of loose stool and to increase fluid intake. |
Source: FDA drug label (KOSELUGO), AstraZeneca Pharmaceuticals LP, effective May 26, 2026 (SPL set 7d042c61-f28f-4ab5-ab10-d7558c0d49ff), via openFDA; the full label on DailyMed
What do FAERS reports show for selumetinib?
The FDA Adverse Event Reporting System holds 1,530 reports that list selumetinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 99 are coded as a death and 289 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
- Selumetinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other