Label Changes for:

Brovana (arformoterol tartrate) Inhalation Solution 

February 2014

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

February 2014

6 ADVERSE REACTIONS

6.2 Clinical Trials Experience
  • Clinical Trial data added…Adults with COPD in Long-Term (52-week) Safety Trial

 

February 2011

 

MEDICATION GUIDE

  • ... information about the risk of serious asthma outcomes (asthma related death, intubations, and hospitalization) ...

 

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