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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: teduglutide [rDNA origin]; teduglutide [rDNA origin]
Trade Name: GATTEX; GATTEX
Date Designated: 06/29/2000
Orphan Designation: Treatment of short bowel syndrome.
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: teduglutide [rDNA origin]; teduglutide [rDNA origin]
Trade Name: GATTEX; GATTEX
Marketing Approval Date: 12/21/2012
Approved Labeled Indication: Treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support
Exclusivity End Date: 12/21/2019 
Exclusivity Protected Indication* :  
2 Generic Name: teduglutide [rDNA origin]; teduglutide [rDNA origin]
Trade Name: GATTEX; GATTEX
Marketing Approval Date: 05/16/2019
Approved Labeled Indication: GATTEX® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Exclusivity End Date: 05/16/2026 
Exclusivity Protected Indication* :  Treatment of pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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