Search Orphan Drug Designations and Approvals
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Generic Name: | irinotecan liposome injection | ||||||||||||||||
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Trade Name: | |||||||||||||||||
Date Designated: | 07/21/2011 | ||||||||||||||||
Orphan Designation: | Treatment of pancreatic cancer | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Ipsen Biopharmaceuticals, Inc. One Main Street Cambridge, Massachusetts 02142 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | irinotecan liposome injection |
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Trade Name: | ||
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 | |
2 | Generic Name: | irinotecan liposome injection |
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Trade Name: | Onivyde | |
Marketing Approval Date: | 02/13/2024 | |
Approved Labeled Indication: | in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | |
Exclusivity End Date: | 02/13/2031 | |
Exclusivity Protected Indication* : | first-line treatment of adult patients with metastatic pancreatic adenocarcinoma | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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