Brief: Orexo Says Co Received Complete Response Letter FDA Regarding New Drug Application (NDA) For Ox124

Orexo AB

16/07/2024 19:03

July 16 (Reuters) - Orexo AB  ORX.ST :
    * OREXO AB - ANNOUNCES THAT COMPANY HAS RECEIVED A COMPLETE
RESPONSE LETTER (CRL) FROM US FOOD AND DRUG ADMINISTRATION
    * OREXO AB  - TO MEET FDA REQUIREMENT, A NEW HF STUDY HAS
BEEN
SUCCESSFULLY COMPLETED
    * OREXO AB - ADDITIONAL TECHNICAL DATA ON FINAL COMMERCIAL
PRODUCT
HAS BEEN REQUESTED
    * OREXO: WORK IN CONSULTATION WITH FDA TO ADDRESS THIS TO
ENABLE
RESUBMISSION OF NDA TO FDA AS SOON AS POSSIBLE
    * OREXO AB - REVIEW PERIOD FOLLOWING RESUBMISSION OF NDA
WILL BE
UP TO SIX MONTHS
    * OREXO AB: RECEIVED COMPLETE RESPONSE LETTER FDA REGARDING
NEW
DRUG APPLICATION (NDA) FOR OX124

Source text for Eikon:  ID:nWkr60HRjK 
Further company coverage:  ORX.ST 

 ((Reuters.Briefs@thomsonreuters.com;))