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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  lurbinectedin
Trade Name:  Zepzelca
Date Designated:  08/01/2018
Orphan Designation:  Treatment of small cell lung cancer (SCLC)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/15/2020 
Approved Labeled Indication:  Zepzelca (lurbinectedin) is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after prior platinum-based chemotherapy.
Exclusivity End Date:    06/15/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
Jazz Pharmaceuticals Ireland Limited
5th Floor Waterloo Exchange
Waterloo Road
Dublin
Ireland

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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