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Schering Corp., Kenilworth, NJ, Dec. 9 (DDMAC).


DDMAC DDMAC Division of Drug Marketing, Advertising and Communications  reviewed a professional detail aid for Schering's Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg and established the aid was misleading because it broadens the indication for Foradil and fails to reveal important risk information.

For example, the first page of the detail aid contained the statement: "For your patients with COPD COPD chronic obstructive pulmonary disease.

COPD
abbr.
chronic obstructive pulmonary disease


Chronic obstructive pulmonary disease (COPD) 
, asthma, or exercise-induced bronchospasm ..."; but the "Indications" section of the Patient Information (PI) specifically states that Foradil "is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta 2-agoinsts."

Foradil is a long-acting selective beta 2-adrenergic receptor agonist, that, when inhaled, acts locally in the lung as a bronchodilator bronchodilator /bron·cho·di·la·tor/ (-di´la-ter)
1. expanding the lumina of the air passages of the lungs.

2. an agent which causes dilatation of the bronchi.
. F-B F-B Forward - Backward (radar image analysis) ; Doc. 13338W
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Title Annotation:CDER/DDMAC Promo Untitled Letters
Publication:Warning Letter Bulletin
Date:Jan 1, 2005
Words:111
Previous Article:AstraZeneca LP, Wilmington, Dec. 21 (DDMAC).(CDER/DDMAC Promo Untitled Letters)
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