FDA panel backs stronger benefit claims for inhaler drug Spiriva marketed by Pfizer
By APThursday, November 19, 2009
FDA panel backs stronger benefits of Spiriva
WASHINGTON — Federal health experts say an inhaler drug from a German drugmaker works well enough to carry bolder claims about reducing coughing, wheezing and other respiratory problems.
The Food and Drug Administration’s panel of lung specialists voted 11-1 to allow Boehringer Ingelheim to add new labeling about the benefits of Spiriva Handihaler, which is approved to treat lung disease.
The FDA is not required to follow the group’s advice though it usually does.
Boehringer Ingelheim has submitted studies to the FDA showing Spiriva reduces specific side effects of chronic obstructive pulmonary disease, such as tightness of the chest and shortness of breath.
Spiriva is co-marketed in the U.S. by Pfizer Inc., the world’s largest drugmaker.
