Label Changes for:
Brovana (arformoterol tartrate) Inhalation Solution
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)
6 ADVERSE REACTIONS
6.2 Clinical Trials Experience
- Clinical Trial data added…Adults with COPD in Long-Term (52-week) Safety Trial
- ... information about the risk of serious asthma outcomes (asthma related death, intubations, and hospitalization) ...