FDA advisory committee to consider OTC NDA for asthma-relieving Primatene HFA

SILVER SPRING, Md. — The Nonprescription Drugs Advisory Committee on Thursday announced it would meet February 25 to discuss data submitted by Armstrong Pharmaceuticals in support of a new drug application for the over-the-counter marketing of Primatene HFA, an epinephrine inhalation aerosol 125 microgram (mcg)/actuation, as a temporary reliever 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.

The following day, the committee will meet to discuss whether OTC bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest, and wheezing) should be removed from the monograph altogether. Specific drugs to be discussed include epinephrine, epinephrine bitartrate and racepinephrine hydrochloride.

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