Brief: Camurus Announces Braeburn Resubmits NDA For Brixadi In The U.S.

Camurus AB

23/11/2022 20:32

Nov 23 (Reuters) - Camurus AB  CAMX.ST :
    * CAMURUS ANNOUNCES THAT BRAEBURN RESUBMITS NDA FOR BRIXADI™
IN
THE US
    * PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE FOR
BRIXADI
IS EXPECTED TO BE ANNOUNCED BY FDA WITHIN 30 DAYS
    * CAMURUS -EXPECTED REVIEW PERIOD AFTER NDA SUBMISSION IS
TWO OR
SIX MONTHS DEPENDING ON AGENCY'S CLASSIFICATION OF RESUBMISSION
AS CLASS 1 OR CLASS 2 REVIEW

Source text for Eikon:  ID:nWkr6S832Z 
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 ((Reuters.Briefs@thomsonreuters.com;))