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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: olaparib
Trade Name: Lynparza
Date Designated: 10/11/2018
Orphan Designation: Treatment of pancreatic cancer
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P.O. Box 8355
Wilmington, Delaware 19803
United States

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

Marketing approved:

1 Generic Name: olaparib
Trade Name: Lynparza
Marketing Approval Date: 12/27/2019
Approved Labeled Indication: Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Exclusivity End Date: 12/27/2026 
Exclusivity Protected Indication* :  Indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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