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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	uridine triacetate
Trade Name:
Date Designated:	05/01/2009
Orphan Designation:	An antidote in the treatment of 5-fluorouracil or capecitabine poisoning
Orphan Designation Status:	Designated/Approved
Sponsor:	BTG International Inc. 300 Four Falls Corporate Center, 300 Conshohocken State Road Suite 300 West Conshohocken, Pennsylvania 19428 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	uridine triacetate
	Trade Name:
	Marketing Approval Date:	12/11/2015
	Approved Labeled Indication:	For the emergency treatment of adult and pediatric patients following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration
	Exclusivity End Date:	12/11/2022
	Exclusivity Protected Indication* :	For the emergency treatment of adult and pediatric patients following a fluorouracil or capecitabine overdose regardless of the presence of symptoms, or who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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