CTI BioPharma announces extension of FDA review period for pacritinib in myelofibrosis with severe thrombocytopenia.
The prescription drug user fee act (pdufa) action date has been extended by three months to february 28, 2022.
In the second quarter of 2021, the FDA granted priority review for CTI's NDA for patients with myelofibrosis with a PDUFA date of November 30, 2021. In the course of product labeling discussions, the FDA requested additional clinical data, which was submitted to the agency on November 24, 2021. Earlier today, the FDA informed the Company that it considers the data submission to constitute a "major amendment" to the NDA and therefore the PDUFA date has been extended by three months to provide additional time for a full review of the submission. At the current time, CTI is not aware of any major deficiencies in the application.
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