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FDA accepts review of pixantrone


The Food and Drug Administration (FDA) has accepted and filed a review for a new Cell Therapeutics’ (CTI) drug for relapsed or refractory aggressive non-Hodgkin’s lymphoma (NHL).

The New Drug Application (NDA) for pixantrone from the Seattle biopharmaceutical company is calling for the FDA to approve the drug as a treatment for NHL, with the agency required to set an action date for review of an application 74 days after the initial submission.

An action date and final decision on review status is expected on September 4 2009.

James Bianco, CEO of CTI, said: “The FDA’s acceptance to file our pixantrone NDA represents a significant milestone for CTI and for patients with relapsed and refractory aggressive NHL. We look forward to working with the FDA and their final decision on our request for priority review.”

Copyright Press Association 2009

Food and Drug Administration

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