Search Orphan Drug Designations and Approvals
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Generic Name: | ibrutinib | ||||||||||||||||
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Trade Name: | Imbruvica | ||||||||||||||||
Date Designated: | 02/02/2016 | ||||||||||||||||
Orphan Designation: | Treatment of patients with extranodal marginal zone lymphoma (mucosa associated lymphoid tissue [MALT type] lymphoma) | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Pharmacyclics, LLC 1000 Gateway Blvd South San Francisco, California 94080 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: | 01/18/2017 | |
Approved Labeled Indication: | Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn) | |
Exclusivity End Date: | 05/18/2023 | |
Exclusivity Protected Indication* : | Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn) | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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