The committees will discuss data submitted by Armstrong Pharmaceuticals, Inc., to support a new drug application (NDA) 205920, for over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (proposed trade name Primatene HFA), for temporary relief of mild symptoms of intermittent asthma for consumers 12 years of age and older.
February 25, 2014 8:30 a.m. to 5:00 p.m.: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary Allergy Drugs Advisory Committee Meeting Announcement
FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The committees will discuss data submitted by Armstrong Pharmaceuticals, Inc., to support a new drug application (NDA) 205920, for over-the-counter (OTC) marketing of epinephrine inhalation aerosol 125 microgram (mcg)/actuation (proposed trade name Primatene HFA), for temporary relief of mild symptoms of intermittent asthma for consumers 12 years of age and older. The epinephrine inhaler was developed as a replacement for Primatene Mist (epinephrine metered inhaler 200 mcg/actuation), an OTC product that was phased out in December 2011 because of the use of chlorofluorocarbons as the propellant. The committee will be asked to consider whether the data support an acceptable risk/benefit profile of the epinephrine inhaler for use by OTC consumers.
Please click HERE for the current roster of the Nonprescription Drugs Advisory Committee.
Please click HERE for the current roster of the Pulmonary Allergy Drugs Advisory Committee.
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