Search Orphan Drug Designations and Approvals
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Generic Name: | durvalumab | ||||||||||||||||
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Trade Name: | Imfinzi | ||||||||||||||||
Date Designated: | 12/10/2020 | ||||||||||||||||
Orphan Designation: | Treatment of biliary tract cancer | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
AstraZeneca Pharmaceuticals LP 1800 Concord Pike Wilmington, Delaware 19803 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: | durvalumab |
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Trade Name: | Imfinzi | |
Marketing Approval Date: | 09/02/2022 | |
Approved Labeled Indication: | In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) | |
Exclusivity End Date: | 09/02/2029 | |
Exclusivity Protected Indication* : | treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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