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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	prothrombin complex concentrate (human)
Trade Name:	Kcentra
Date Designated:	12/27/2012
Orphan Designation:	Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures
Orphan Designation Status:	Designated/Approved
Sponsor:	CSL Behring 1020 First Avenue PO Box 61501 King of Prussia, Pennsylvania 19406 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	prothrombin complex concentrate (human)
	Trade Name:	Kcentra
	Marketing Approval Date:	04/29/2013
	Approved Labeled Indication:	Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
	Exclusivity End Date:	04/29/2020
	Exclusivity Protected Indication* :	Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.

2	Generic Name:	prothrombin complex concentrate (human)
	Trade Name:	Kcentra
	Marketing Approval Date:	12/13/2013
	Approved Labeled Indication:	Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure.
	Exclusivity End Date:	12/13/2020
	Exclusivity Protected Indication* :	Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, e.g., warfarin) in adult patients with the need for urgent surgery/invasive procedure.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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