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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  irinotecan liposome injection
Trade Name:  
Date Designated:  07/21/2011
Orphan Designation:  Treatment of pancreatic cancer
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/22/2015 
Approved Labeled Indication:  For use in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas that has progressed following gemcitabine-based therapy
Exclusivity End Date:    10/22/2022 
Exclusivity Protected Indication* :  For use in combination with 5-fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas that has progressed following gemcitabine-based therapy
Ipsen Bioscience,Inc.
650 East Kendall Street
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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