Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	imatinib
Trade Name:	Gleevec
Date Designated:	10/11/2005
Orphan Designation:	Treatment of Philadelphia-positive acute lymphoblastic 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
	Trade Name:	Gleevec
	Marketing Approval Date:	10/19/2006
	Approved Labeled Indication:	Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)
	Exclusivity End Date:	10/19/2013
	Exclusivity Protected Indication* :

2	Generic Name:	imatinib
	Trade Name:	Gleevec
	Marketing Approval Date:	01/25/2013
	Approved Labeled Indication:	Pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
	Exclusivity End Date:	01/25/2020
	Exclusivity Protected Indication* :	Treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy

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