Search Orphan Drug Designations and Approvals
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Generic Name: | lenalidomide | ||||||||||||||||
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Trade Name: | Revlimid | ||||||||||||||||
Date Designated: | 09/20/2001 | ||||||||||||||||
Orphan Designation: | Treatment of multiple myeloma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Celgene Corporation 86 Morris Avenue Summit, New Jersey 07901 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | lenalidomide |
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Trade Name: | Revlimid | |
Marketing Approval Date: | 06/29/2006 | |
Approved Labeled Indication: | For use in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy | |
Exclusivity End Date: | 06/29/2013 | |
Exclusivity Protected Indication* : | ||
2 | Generic Name: | lenalidomide |
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Trade Name: | Revlimid | |
Marketing Approval Date: | 02/17/2015 | |
Approved Labeled Indication: | REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM). | |
Exclusivity End Date: | 02/17/2022 | |
Exclusivity Protected Indication* : | For use in combination with dexamethasone for the treatment of patients with multiple myeloma who have not received at least one prior therapy (first-line therapy). | |
3 | Generic Name: | lenalidomide |
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Trade Name: | Revlimid | |
Marketing Approval Date: | 02/22/2017 | |
Approved Labeled Indication: | Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) | |
Exclusivity End Date: | 02/22/2024 | |
Exclusivity Protected Indication* : | Treatment of multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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