Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	Imatinib mesylate
Trade Name:	Gleevec
Date Designated:	09/09/2005
Orphan Designation:	Treatment of systemic mastocytosis without the D816V c-kit mutation
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 aggressive mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown
	Exclusivity End Date:	10/19/2013
	Exclusivity Protected Indication* :

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