Citius Pharma Resubmits BLA Of Lymphir To FDA

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) announced the resubmission of the Biologics License Application or BLA of Lymphir to the FDA on Wednesday.

The resubmission follows concerns raised in the Complete Response Letter received on July 28, 2023.

As per the Center for Drug Evaluation and Research timelines, the FDA is anticipated to provide a Prescription Drug User Fee Act date within 30 days of the resubmission.

Lymphir, also known as denileukin diftitox, is IL-2-based immunotherapy designed for patients with relapsed or refractory cutaneous T-cell lymphoma who have received at least one prior systemic therapy.