Brief: Aquestive Therapeutics Receives FDA Response To Citizen’S Petition

Allon Therapeutics

12/01/2020 23:51

Jan 12 (Reuters) - Aquestive Therapeutics Inc  AQST.O :
    * AQUESTIVE THERAPEUTICS RECEIVES FDA RESPONSE TO CITIZEN’S
PETITION
    * U.S. FDA ISSUED RESPONSE LETTER DATED JANUARY 10 DENYING
CO'S
CITIZEN'S PETITION RECEIVED BY FDA ON NOV 1, 2019
    * PETITION REQUESTED FDA STAY APPROVAL OF NEW DRUG
APPLICATION FOR
VALTOCO SUBMITTED BY NEURELIS UNTIL MORE CLINICAL STUDIES WERE
CONDUCTED
    * IN RESPONSE, FDA INDICATED THAT IT HAD APPROVED NEURELIS'S
NDA
FOR VALTOCO ON JANUARY 10, 2020
    * FDA ALSO DENIED SUPPLEMENT TO CITIZEN'S PETITION RECEIVED
BY FDA
ON DECEMBER 4, 2019

Source text for Eikon:  ID:nGNX73XqW5 
Further company coverage:  AQST.O 

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