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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.
2000 Sierra Point Parkway
Suite 501
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: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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