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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  selumetinib
Trade Name:  
Date Designated:  02/14/2018
Orphan Designation:  Treatment of Neurofibromatosis Type 1
Orphan Designation Status:  Designated/Approved
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).
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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