Skip to Content

Revlimid Approval History

Revlimid (lenalidomide) is an immunomodulatory drug indicated for the treatment of patients with multiple myeloma, transfusion-dependent anemia due myelodysplastic syndromes (MDS), and mantle cell lymphoma.

Development History and FDA Approval Process for Revlimid

DateArticle
Feb 18, 2015Approval FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma
Jun  5, 2013Approval FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma
Oct  3, 2005Revlimid PDUFA Date Extended Three Months By FDA
Sep 14, 2005FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
Sep 13, 2005FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online
Jun 21, 2005FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
Jun  7, 2005Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA
Apr  8, 2005Revlimid New Drug Application Submitted to FDA for Review

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide