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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Glutamine
Trade Name: NutreStore
Date Designated: 03/06/1995
Orphan Designation: For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface).
Orphan Designation Status: Designated/Approved
Emmaus Medical, Inc.
20725 S. Western Avenue
Suite 136
Torrence, California 90501
United States

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

Marketing approved:

1 Generic Name: Glutamine
Trade Name: NutreStore
Marketing Approval Date: 06/10/2004
Approved Labeled Indication: Treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth hormone that is approved for this indication.
Exclusivity End Date: 06/10/2011 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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