Brief: Hyloris Says FDA Requests Additional Data For Maxigesic IV

Hyloris Pharmaceuticals SA

01/07/2022 09:29

July 1 (Reuters) - HYLORIS PHARMACEUTICALS SA  HYL.BR :
    * US FDA SEEKS MORE INFORMATION ON MAXIGESIC IV® APPLICATION
    * ANNOUNCES THAT IT HAS TODAY RECEIVED A COMPLETE RESPONSE
LETTER
(CRL) FROM US FDA ON ITS APPLICATION FOR US REGISTRATION OF
MAXIGESIC IV®
    * FDA HAS ONLY REQUESTED ADDITIONAL DATA ON ONE REMAINING
TOPIC
    * WILL ALLOW PRODUCT TO FULFILL ITS FULL COMMERCIAL
POTENTIAL IN
US AND NOT AFFECT COMPANY'S OTHER EXISTING DEVELOPMENT PROGRAMS
    * ADDITIONAL WORK REQUIRED BY FDA FALLS WELL WITHIN
PARAMETERS OF
OUR NORMAL OPERATIONAL BUDGET AND WILL BE COMPLETED
EXPEDITIOUSLY - CEO

Source text for Eikon:  ID:nGNE1sNKFl 
Further company coverage:  HYL.BR 

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