Brief: Cumberland Says FDA Informed Submission For Update To Caldolor Was Not Accepted For Review

Cumberland Pharmaceuticals

10/09/2019 22:39

Sept 10 (Reuters) - Cumberland Pharmaceuticals Inc  CPIX.O :
    * CUMBERLAND - IN EARLY SEPT, FDA INFORMED SUBMISSION FOR
UPDATE
TO CALDOLOR WAS NOT ACCEPTED FOR THEIR REVIEW BECAUSE OF NUMBER
OF NEW CLAIMS
    * CUMBERLAND - FDA RECOMMENDED SPLITTING SUBMISSION INTO
SEVERAL
SEPARATE SUBMISSIONS, WITH ADDITIONAL DATA IN SUPPORT OF EACH
CLAIM
    * CUMBERLAND PHARMACEUTICALS INC - FDA OFFERED A TYPE A
MEETING TO
DISCUSS THEIR RECOMMENDATIONS, WHICH WE INTEND TO SCHEDULE.
    * CUMBERLAND PHARMACEUTICALS INC - EVALUATING FDA'S RESPONSE

Source text: (http://www.sec.gov/Archives/edgar/data/1087294/000162828019011597/0001628280-19-011597-index.htm)
Further company coverage:  CPIX.O 

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