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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: voxelotor
Trade Name: Oxbryta
Date Designated: 12/29/2015
Orphan Designation: Treatment of sickle cell disease
Orphan Designation Status: Designated/Approved
Global Blood Therapeutics, Inc.
181 Oyster Point Blvd
South San Francisco, California 94080
United States

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

Marketing approved:

1 Generic Name: voxelotor
Trade Name: Oxbryta
Marketing Approval Date: 11/25/2019
Approved Labeled Indication: OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
Exclusivity End Date: 11/25/2026 
Exclusivity Protected Indication* :  Indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
2 Generic Name: voxelotor
Trade Name: Oxbryta
Marketing Approval Date: 12/17/2021
Approved Labeled Indication: treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older
Exclusivity End Date: 12/17/2028 
Exclusivity Protected Indication* :  treatment of sickle cell disease (SCD) in pediatric patients 4 years of age to less than 12 years of age
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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