Search Orphan Drug Designations and Approvals
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Generic Name: | niraparib | ||||||||||||||||
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Trade Name: | Zejula | ||||||||||||||||
Date Designated: | 04/30/2010 | ||||||||||||||||
Orphan Designation: | Treatment of ovarian cancer | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
GlaxoSmithKline, LLC. 1000 Winter St. Suite 3300 Waltham, Massachusetts 02451 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: | niraparib |
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Trade Name: | Zejula | |
Marketing Approval Date: | 03/27/2017 | |
Approved Labeled Indication: | Indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy | |
Exclusivity End Date: | 03/27/2024 | |
Exclusivity Protected Indication* : | Indicated for maintenance treatment of adult patients with recurrent epithelial ovarian cancer who are in a complete or partial response to platinum-based chemotherapy | |
2 | Generic Name: | niraparib |
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Trade Name: | Zejula | |
Marketing Approval Date: | 10/23/2019 | |
Approved Labeled Indication: | ZEJULA? is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either, (1) a deleterious or suspected deleterious BRCA mutation, or (2) genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy (Indication withdrawn) | |
Exclusivity End Date: | 09/14/2022 | |
Exclusivity Protected Indication* : | Indicated for the treatment of adult patients with advanced ovarian cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy (Indication withdrawn) | |
3 | Generic Name: | niraparib |
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Trade Name: | Zejula | |
Marketing Approval Date: | 04/29/2020 | |
Approved Labeled Indication: | ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy | |
Exclusivity End Date: | 04/29/2027 | |
Exclusivity Protected Indication* : | Indicated for the maintenance treatment of adult patients with advanced epithelial ovarian cancer who are in a complete or partial response to first-line platinum-based chemotherapy. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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