Denileukin Diftitox-Cxdl

Treats relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least…. Sold as Lymphir. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Denileukin Diftitox-Cxdl (sold as Lymphir), first approved Aug 7, 2024, with 0 new uses approved and 1 published complete response letter.

First approved: Aug 7, 2024
Applications: 1
New uses approved: 0
Complete response letters: 1
First approved in Japan: Mar 23, 2021

Orphan Designations (FDA)

4 designations, 2 approved for the designated use; see all orphan designations

Treatment of cutaneous T-cell lymphomaCitius Oncology, Inc. · designated Jul 12, 2013 · approved Aug 7, 2024
treatment of peripheral T-cell lymphoma (PTCL)Citius Oncology, Inc. · designated Jun 29, 2011
Treatment of peripheral T-cell lymphomaEisai, Inc. · designated Apr 30, 2010
Treatment of patients with cutaneous T-cell lymphomaEisai, Inc. · designated Aug 21, 1996 · approved Feb 5, 1999

Approvals in Japan (PMDA)

First approved in Japan 41 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Remitoro, new ingredientA drug with a new active ingredient indicated for the treatment of relapsed or refractory peripheral T-cell lymphoma and relapsed or refractory cutaneous… · Eisai Co., Ltd. · Mar 23, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Aug 7, 2024	LymphirBLA 761312 · New formulation or manufacturer	Citius Pharms	0	Marketed

Complete Response Letters

FDA's published letters for these applications

Letter	Product	Now
Jul 28, 2023	Lymphir (denileukin diftitox-cxdl)Product Quality, Facility Inspections	Approved

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA