Biopharmaceutical company Cell Therapeutics Inc (CTIC) Tuesday announced that the US Food and Drug Administration's Division of Oncology Products has notified to the company that its October 2011 resubmitted New Drug Application is considered a complete, Class 2 response to the FDA's April 2010 complete response letter.
The company further noted that the FDA has set a Prescription Drug User Fee Act, or PDUFA, goal date of April 24, 2012 for a decision on the new drug application, or NDA.
The NDA seeks accelerated approval of pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.
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September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.