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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