Treats relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least…. BLA 761312, held by Citius Pharms. Denileukin Diftitox-Cxdl.
As of Nov 13, 2026, BLA 761312 (Lymphir), held by Citius Pharms, was first approved by FDA on Aug 7, 2024, with 0 approved supplements and 1 published complete response letter.
LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 28, 2023 | Lymphir (denileukin diftitox-cxdl)Product Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lymphir300MCG · injectable;injection | Denileukin Diftitox-Cxdl | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
