Search Orphan Drug Designations and Approvals
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Generic Name: | duvelisib | ||||||||||||||||
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Trade Name: | COPIKTRA | ||||||||||||||||
Date Designated: | 08/01/2013 | ||||||||||||||||
Orphan Designation: | Treatment of follicular lymphoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Secura Bio, Inc. 1995 Village Center Cir. Suite 128 Las Vegas, Nevada 89134-6360 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: | duvelisib |
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Trade Name: | COPIKTRA | |
Marketing Approval Date: | 09/24/2018 | |
Approved Labeled Indication: | Treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior therapies (Indication withdrawn) | |
Exclusivity End Date: | 12/17/2021 | |
Exclusivity Protected Indication* : | Treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior therapies (Indication withdrawn) | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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