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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 (SCD).
Orphan Designation Status:  Designated/Approved
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.
Global Blood Therapeutics, Inc.
171 Oyster Point Blvd
Suite 300
South San Francisco, California 94080
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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