Cell Therapeutics Inc. Dec. 6 announced that the Food and Drug Administration has notified the company that its resubmitted new drug application for pixantrone is considered complete.
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, the Seattle-based company said.
FDA issued a complete response letter for the original pixantrone NDA in April 2010. CTI appealed the complete response letter based on the results of the PIX301 clinical trial (8 PLIR 1561, 12/10/10).
FDA responded to CTI’s appeal by providing CTI ...
Learn more about Bloomberg Law or Log In to keep reading:
See Breaking News in Context
Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.
Already a subscriber?
Log in to keep reading or access research tools and resources.