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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tovorafenib
Trade Name: Ojemda
Date Designated: 09/24/2020
Orphan Designation: Treatment of malignant glioma
Orphan Designation Status: Designated/Approved
Day One Biopharmaceuticals, Inc.
1800 Sierra Point Parkway, Suite 200
Brisbane, California 94005
United States

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

Marketing approved:

1 Generic Name: tovorafenib
Trade Name: Ojemda
Marketing Approval Date: 04/23/2024
Approved Labeled Indication: treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
Exclusivity End Date: 04/23/2031 
Exclusivity Protected Indication* :  treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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