FDA asks Citius for enhanced product testing in CRL for non-Hodgkin lymphoma drug Lymphir
The FDA hit Citius Pharmaceuticals with a complete response letter (CRL) for its treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma.
The agency wants to see “enhanced product testing” and “additional controls” that the company agreed to with the FDA during the market application review of denileukin diftitox, marketed as Lymphir. Citius noted the CRL had nothing to do with safety, efficacy or the prescribing information.
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