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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
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.

Marketing approved:

1 Generic Name: lurbinectedin
Trade Name: Zepzelca
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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