Search Orphan Drug Designations and Approvals
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Generic Name: | lurbinectedin |
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Trade Name: | Zepzelca |
Date Designated: | 08/01/2018 |
Orphan Designation: | Treatment of small cell lung cancer (SCLC) |
Orphan Designation Status: | Designated/Approved |
Sponsor: |
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: |
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1 | Generic Name: | lurbinectedin |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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