Brief: Camurus AB Says Braeburn Receives New Complete Response Letter For Brixadi In The U.S.

Camurus AB

15/12/2021 22:07

Dec 15 (Reuters) - Camurus AB  CAMX.ST :
    * BRAEBURN RECEIVES NEW COMPLETE RESPONSE LETTER FOR BRIXADI
IN
THE US
    * US LICENSEE BRAEBURN HAS RECEIVED A COMPLETE RESPONSE
LETTER
FROM US FDA FOR ITS UPDATED NEW DRUG APPLICATION FOR BRIXADI
    * SEEKING FURTHER INFORMATION FROM BRAEBURN AND WILL
CONSIDER ALL
OPTIONS TO ENSURE THAT BRIXADI BECOMES AVAILABLE TO U.S.
PATIENTS
    * CRL RESULT OF CONTINUED QUALITY RELATED DEFICIENCIES AT
BRAEBURN'S US BASED THIRD PARTY MANUFACTURER, IDENTIFIED BY FDA
DURING PRE-APPROVAL INSPECTION
    * WILL PROVIDE FURTHER UPDATES AS SOON AS ADDITIONAL
RELEVANT
INFORMATION HAS BEEN RECEIVED FROM BRAEBURN

Source text for Eikon:  ID:nWkr1Vzv8X 
Further company coverage:  CAMX.ST 

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