The FDA’s Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Advisory Committee (PADAC) will meet on February 25, 2014 to consider a new drug application submitted by Armstrong Pharmaceuticals for an OTC epinephrine inhalation aerosol for the treatment of mild asthma. Armstrong, which is owned by Amphastar, marketed the Primatene Mist OTC epinephrine inhaler until it was phased out at the end of December 2011 in accordance with the Montreal Protocol.
At the time of the phase-out, Armstrong said that it was working on an HFA version of the inhaler, and the current NDA is for an HFA formulation with the proposed trade name Primatene HFA. The proposed HFA inhaler has a lower dosage of epinephrine than the CFC formulation: 125 mcg/actuation compared to 200 mcg/actuation.
Read the FDA meeting announcement.
