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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
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
Exclusivity End Date:    12/19/2023 
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
Clovis Oncology, Inc.
5500 Flatiron Parkway
Suite 100
Boulder, Colorado 80301
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  rucaparib
Trade Name:  Rubraca
Date Designated:  07/31/2012
Orphan Designation:  Treatment of ovarian cancer
Orphan Designation Status:  Designated/Approved
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.
Clovis Oncology, Inc.
5500 Flatiron Parkway
Suite 100
Boulder, Colorado 80301
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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