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CTI BioPharma Announces FDA Acceptance Of NDA Granted With Priority Review Of Pacritinib For Treatment Of Patients With Myelofibrosis


Benzinga | Jun 1, 2021 07:03AM EDT

CTI BioPharma Announces FDA Acceptance Of NDA Granted With Priority Review Of Pacritinib For Treatment Of Patients With Myelofibrosis

CTI BioPharma Corp. (NASDAQ:CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L), with the NDA being granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is November 30, 2021. The FDA is not currently planning to hold an advisory committee meeting to discuss the NDA.






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