Citius 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

Prescription drug user fee act (pdufa) target action date is september 28, 2023 cranford, n.j. , dec. 1, 2022 /prnewswire/ -- citius pharmaceuticals, inc. ("citius" or the "company") (nasdaq: ctxr), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the u.s. food and drug administration (fda) has accepted the company's biologics license application (bla) for denileukin diftitox ("i/ontak" or "e7777"), an engineered il-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous t-cell lymphoma (ctcl).
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