Brief: Eton Pharmaceuticals Receives Complete Response Letter (CRL) For Dehydrated Alcohol Injection

Eton Pharmaceuticals

28/06/2023 11:59

June 28 (Reuters) - Eton Pharmaceuticals Inc  ETON.O :
    * ETON PHARMACEUTICALS RECEIVES COMPLETE RESPONSE LETTER
(CRL) FOR
DEHYDRATED ALCOHOL INJECTION
    * ETON PHARMACEUTICALS INC: BELIEVES ALL ISSUES IN CRL ARE
ADDRESSABLE AND WILL DEVELOP A COMPREHENSIVE ACTION PLAN TO
ADDRESS FDA'S CONCERNS
    * ETON PHARMACEUTICALS INC - ISSUES RAISED IN CRL RELATE
PRIMARILY
TO CHEMISTRY MANUFACTURING AND CONTROLS
    * ETON PHARMACEUTICALS : FDA ISSUED CRL IN RESPONSE TO CO'S
NDA
FOR DEHYDRATED ALCOHOL INJECTION FOR TREATMENT OF METHANOL
POISONING

Source text for Eikon:  ID:nGNX2VxV67 
Further company coverage:  ETON.O 

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