1. 1 Joint NDAC/PADAC Meeting January 24, 2005 Determination of “Essential Use” Status of CFC-based Epinephrine MDIs for Nonprescription Treatment of Asthma Charles J. Ganley, M.D. Director, Office of Nonprescription Products January 24, 2006

2. 2 Joint NDAC/PADAC Meeting January 24, 2005 Products Affected NDA 16-126 (Wyeth) –Epinephrine 0.2 mg per inhalation –Epinephrine bitartrate 0.3 mg per inhalation aNDA 87-907 (Armstrong) –Epinephrine 0.2 mg per inhalation

3. 3 Joint NDAC/PADAC Meeting January 24, 2005 Marketing of Nonprescription Drugs for Asthma New Drug Applications Metered Dose Inhalers OTC Monograph Oral –Ephedrine –Ephedrine Hydrochloride –Ephedrine Sulfate –Racephedrine Hydrochloride Bulb Nebulizer –Epinephrine –Epinephrine Bitartrate –Racepinephrine Hydrochloride

4. 4 Joint NDAC/PADAC Meeting January 24, 2005 Questions Asked in FR Notice of Meeting Who currently uses OTC epinephrine MDIs? How many of these MDIs are used annually? What are the alternatives if these products are no longer available? From literature sources, what is the value of use of the product to the users, and why do they use it? What established treatment guidelines recommend the use of OTC epinephrine? How many people with asthma do not have ready access to prescription medication through healthcare professionals?