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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: L-glutamine
Trade Name: Endari
Date Designated: 08/01/2001
Orphan Designation: Treatment of sickle cell disease
Orphan Designation Status: Designated/Approved
Emmaus Medical, Inc.
21250 Hawthorne Blvd., Suite 800
Torrance, California 90503
United States

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

Marketing approved:

1 Generic Name: L-glutamine
Trade Name: Endari
Marketing Approval Date: 07/07/2017
Approved Labeled Indication: To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
Exclusivity End Date: 07/07/2024 
Exclusivity Protected Indication* :  To reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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