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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	lenalidomide
Trade Name:	Revlimid
Date Designated:	09/20/2001
Orphan Designation:	Treatment of multiple myeloma
Orphan Designation Status:	Designated/Approved
Sponsor:	Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	lenalidomide
	Trade Name:	Revlimid
	Marketing Approval Date:	06/29/2006
	Approved Labeled Indication:	For use in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy
	Exclusivity End Date:	06/29/2013
	Exclusivity Protected Indication* :

2	Generic Name:	lenalidomide
	Trade Name:	Revlimid
	Marketing Approval Date:	02/17/2015
	Approved Labeled Indication:	REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM).
	Exclusivity End Date:	02/17/2022
	Exclusivity Protected Indication* :	For use in combination with dexamethasone for the treatment of patients with multiple myeloma who have not received at least one prior therapy (first-line therapy).

3	Generic Name:	lenalidomide
	Trade Name:	Revlimid
	Marketing Approval Date:	02/22/2017
	Approved Labeled Indication:	Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)
	Exclusivity End Date:	02/22/2024
	Exclusivity Protected Indication* :	Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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