Cumberland falls as FDA declines application for expanded label of pain drug

Cumberland Pharmaceuticals

11/09/2019 18:14

** Drug developer's shares  CPIX.O  fall ~8% to $4.9
    ** Co says the U.S. FDA did not agree to review its
application to expand the label for its pain drug Caldolor to
include additional safety information, among others  urn:newsml:reuters.com:*:nFWN2610T8
    ** Says the FDA recommended splitting up the submission into
several separate ones, each containing a single proposed
labeling claim or group of related labeling claims
    ** Intends to meet the agency to discuss the recommendations
    ** Caldolor is approved for fever, management of mild to
moderate pain and as an adjunct to opioid analgesics for the
management of moderate to severe pain 
    ** Up to Tuesday's close, CPIX had dropped ~13% YTD

 (Reporting by Manojna Maddipatla in Bengaluru)
 ((manojna.kalyani@thomsonreuters.com; within the U.S. +1 646
223 8780, outside the U.S. +91  80 6749 1692))