Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: selumetinib
Trade Name:
Date Designated: 02/14/2018
Orphan Designation: Treatment of Neurofibromatosis Type 1
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: selumetinib
Trade Name:
Marketing Approval Date: 04/10/2020
Approved Labeled Indication: KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Exclusivity End Date: 04/10/2027 
Exclusivity Protected Indication* :  Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
2 Generic Name: selumetinib
Trade Name: Koselugo
Marketing Approval Date: 09/10/2025
Approved Labeled Indication: treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Exclusivity End Date: 09/10/2032 
Exclusivity Protected Indication* :  treatment of pediatric patients 1 year of age to less than 2 years of age with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
3 Generic Name: selumetinib
Trade Name: Koselugo
Marketing Approval Date: 11/19/2025
Approved Labeled Indication: treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Exclusivity End Date: 11/19/2032 
Exclusivity Protected Indication* :  treatment of adult patients with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-