Treats neurofibromatosis type 1 (NF1). NDA 219943, held by Astrazeneca. Selumetinib Sulfate, Selumetinib.
As of Nov 13, 2026, NDA 219943 (Koselugo), held by Astrazeneca, was first approved by FDA on Sep 10, 2025, with 2 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).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2025 | Original applicationNew dosage form · Priority review | Approved |
| KoselugoEQ 5MG BASE · granule;oral | Selumetinib Sulfate | RxReference drug |
| KoselugoEQ 7.5MG BASE · granule;oral | Selumetinib Sulfate | RxReference drug |
| Koselugo10MG · capsule; oral | Selumetinib | Rx |
| Koselugo25MG · capsule; oral | Selumetinib | Rx |
| May 26, 2026 | Supplement 3Labeling · Standard review | Approved | |
| Nov 19, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Sep 10, 2025 | Original applicationNew dosage form · 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
