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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rucaparib
Trade Name: Rubraca
Date Designated: 07/31/2012
Orphan Designation: Treatment of ovarian cancer
Orphan Designation Status: Designated/Approved
pharma&
Taborstrasse 1
Wien 1020
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: rucaparib
Trade Name: Rubraca
Marketing Approval Date: 12/19/2016
Approved Labeled Indication: As monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies (Indication withdrawn)
Exclusivity End Date: 06/10/2022 
Exclusivity Protected Indication* :  As monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies (Indication withdrawn)
2 Generic Name: rucaparib
Trade Name: Rubraca
Marketing Approval Date: 04/06/2018
Approved Labeled Indication: For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
Exclusivity End Date: 04/06/2025 
Exclusivity Protected Indication* :  For the maintenance treatment of adult patients with recurrent epithelial ovarian cancer who are in complete or partial response to platinum-based chemotherapy.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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