Brief: CTI Biopharma Announces Extension Of FDA Review Period For Pacritinib

CTI Biopharma

30/11/2021 23:17

Nov 30 (Reuters) - CTI Biopharma Corp  CTIC.O :
    * CTI BIOPHARMA ANNOUNCES EXTENSION OF FDA REVIEW PERIOD FOR
PACRITINIB IN MYELOFIBROSIS WITH SEVERE THROMBOCYTOPENIA
    * CTI BIOPHARMA CORP - PRESCRIPTION DRUG USER FEE ACT
(PDUFA)
ACTION DATE HAS BEEN EXTENDED BY THREE MONTHS TO FEBRUARY 28,
2022
    * CTI BIOPHARMA CORP - FDA INFORMED CO THAT IT CONSIDERS
DATA
SUBMISSION TO CONSTITUTE A "MAJOR AMENDMENT" TO NDA
    * CTI BIOPHARMA CORP -  AT CURRENT TIME, NOT AWARE OF ANY
MAJOR
DEFICIENCIES IN NDA FOR PACRITINIB
    * CTI BIOPHARMA - IN COURSE OF PRODUCT LABELING DISCUSSIONS,
FDA
REQUESTED ADDITIONAL CLINICAL DATA, WHICH WAS SUBMITTED TO
AGENCY ON NOV 24, 2021

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