Search Orphan Drug Designations and Approvals
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Generic Name: | ibrutinib | ||||||||||||||||
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Trade Name: | Imbruvica | ||||||||||||||||
Date Designated: | 12/03/2012 | ||||||||||||||||
Orphan Designation: | Treatment of mantle cell lymphoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Pharmacyclics, LLC 995 E. Arques Avenue Sunnyvale, California 94085 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: | ibrutinib |
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Trade Name: | Imbruvica | |
Marketing Approval Date: | 11/13/2013 | |
Approved Labeled Indication: | Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | |
Exclusivity End Date: | 11/13/2020 | |
Exclusivity Protected Indication* : | Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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