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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pexidartinib
Trade Name: TURALIO
Date Designated: 02/14/2014
Orphan Designation: Treatment of pigmented villonodular synovitis/giant cell tumor of the tendon sheath
Orphan Designation Status: Designated/Approved
Daiichi Sankyo, Inc.
211 Mount Airy Road
Basking Ridge, New Jersey 07920
United States

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

Marketing approved:

1 Generic Name: pexidartinib
Trade Name: TURALIO
Marketing Approval Date: 08/02/2019
Approved Labeled Indication: TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
Exclusivity End Date: 08/02/2026 
Exclusivity Protected Indication* :  For the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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