Treats neurofibromatosis type 1 (NF1). NDA 213756, held by Astrazeneca. Selumetinib Sulfate.
As of Nov 13, 2026, NDA 213756 (Koselugo), held by Astrazeneca, was first approved by FDA on Apr 10, 2020, with 5 approved supplements and 0 published complete response letters.
KOSELUGO 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).
| Nov 19, 2025 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 10, 2025 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jan 24, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| KoselugoEQ 10MG BASE · capsule;oral | Selumetinib Sulfate | RxReference drug |
| KoselugoEQ 25MG BASE · capsule;oral | Selumetinib Sulfate | RxReference drug |
| May 26, 2026 | Supplement 7Labeling · Standard review | Approved | |
| Nov 19, 2025 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Sep 10, 2025 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jan 24, 2024 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Apr 10, 2020 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
