Brief: Reata Pharmaceuticals Announces Three Month Extension Of The Review Period For New Drug Application For The Treatment Of Friedreich’S Ataxia

Reata Pharmaceuticals

09/08/2022 13:06

Aug 9 (Reuters) - Reata Pharmaceuticals Inc  RETA.O :
    * REATA PHARMACEUTICALS ANNOUNCES THREE MONTH EXTENSION OF
THE
REVIEW PERIOD FOR NEW DRUG APPLICATION FOR OMAVELOXOLONE FOR THE
TREATMENT OF FRIEDREICH’S ATAXIA
    * REATA PHARMACEUTICALS INC - PDUFA DATE EXTENDED TO
FEBRUARY 28,
2023
    * REATA PHARMACEUTICALS INC - FDA EXTENDED PDUFA DATE TO
PROVIDE
TIME FOR FULL REVIEW OF NEW SUBMISSIONS
    * REATA PHARMACEUTICALS INC - REATA SUBMITTED NEW DATA AND
ANALYSES TO ADDRESS FDA QUESTIONS DURING MID-CYCLE MEETING
    * REATA PHARMACEUTICALS INC - FDA PUT PLANNED ADVISORY
COMMITTEE
MEETING ON HOLD PENDING REVIEW OF NEW NDA AMENDMENTS

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