Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	Imatinib mesylate
Trade Name:	Gleevec
Date Designated:	08/25/2005
Orphan Designation:	Treatment of idiopathic hypereosinophilic syndrome including acute and chronic eosinophilic leukemia
Orphan Designation Status:	Designated/Approved
Sponsor:	Novartis Pharmaceuticals Corporation One Health Plaza Mail Code 105/1E870D East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	Imatinib mesylate
	Trade Name:	Gleevec
	Marketing Approval Date:	10/19/2006
	Approved Labeled Indication:	Treatment of adult patients with hypereosinophic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRÿ}ÿ± fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRÿ}ÿ± fusion kinase negative or unknown
	Exclusivity End Date:	10/19/2013
	Exclusivity Protected Indication* :

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.