FDA to study OTC ozone-depleting asthma inhalers

January 23, 2006

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A joint FDA advisory panel this month will discuss essential use determinations for OTC epinephrine metered-dose asthma inhalers that contain ozone-depleting substances (ODSs). According to the agency's notice of the Jan. 24 meeting of the joint Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committees, there are some marketed drug products containing epinephrine in a metered-dose inhaler (MDI) form. Under section 610 of the Clean Air Act, MDIs that are not the subject of an essential-use designation cannot be legally distributed. The panelists will discuss the continued need for the essential-use designation for these products. For more information, visit http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html.