Search Orphan Drug Designations and Approvals
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Generic Name: | dasatinib | |||||||||||||
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Trade Name: | Phyrago | |||||||||||||
Date Designated: | 10/05/2021 | |||||||||||||
Orphan Designation: | Treatment of acute lymphoblastic leukemia | |||||||||||||
Orphan Designation Status: | Designated/Approved | |||||||||||||
Sponsor: |
Nanocopoeia, LLC 639 Campus Drive New Brighton, Minnesota 55112 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: | dasatinib |
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Trade Name: | Phyrago | |
Marketing Approval Date: | 12/05/2023 | |
Approved Labeled Indication: | treatment of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy | |
Exclusivity End Date: | TBD | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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