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Lymphir FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 12, 2024.

FDA Approved: Yes (First approved August 7, 2024)
Brand name: Lymphir
Generic name: denileukin diftitox-cxdl
Dosage form: for Injection
Company: Citius Pharmaceuticals, Inc.
Treatment for: Cutaneous T-cell Lymphoma

Lymphir (denileukin diftitox-cxdl) is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.

Development timeline for Lymphir

DateArticle
Aug  8, 2024Approval FDA Approves Lymphir (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
Feb 13, 2024Citius Pharmaceuticals Resubmits the Biologics License Application of Lymphir (denileukin diftitox) for the Treatment of Adults With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Jul 29, 2023Citius Pharmaceuticals, Inc. Receives A Complete Response Letter From The U.S. Food And Drug Administration (FDA) For Lymphirâ„¢ (Denileukin Diftitox) For The Treatment Of Patients With Relapsed Or Refractory Cutaneous T-Cell Lymphoma
Dec  1, 2022Citius Pharmaceuticals, Inc. Announces U.S. Food And Drug Administration Acceptance Of Biologics License Application Of Denileukin Diftitox For The Treatment Of Patients With Persistent Or Recurrent Cutaneous T-Cell Lymphoma
Sep 28, 2022Citius Pharmaceuticals, Inc. Submits Biologics License Application To The U.S. Food And Drug Administration For Denileukin Diftitox For The Treatment Of Patients With Persistent Or Recurrent Cutaneous T-Cell Lymphoma

Further information

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