Amphastar announced that the Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Armstrong regarding the New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol). 

The CRL informed that the application could not be approved in its present form. Armstrong was requested to make further modifications to the drug label and packaging for Primatene Mist and to conduct another Human Factor validation study to assess consumers’ ability to use the product without the guidance of a physician or pharmacist. 

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The previous Primatene Mist was the only FDA-approved epinephrine inhaler available over-the-counter (OTC) for the temporary relief of occasional symptoms of mild asthma. The new version of Primatene Mist contains the same active ingredient that was found in the original but without the chlorofluorocarbons (CFCs) that were phased out in 2011 as part of an international environmental treaty. Since then, manufacturers have changed their inhalers to replace CFCs with an environment-friendly propellant, hydrofluoroalkane (HFA). The new Primatene Mist includes other new features such as a built-in spray indicator and a pressurized metal canister that replaces the glass container used in the original Primatene Mist. 

Amphastar plans to address all of the FDA’s concerns by mid-2017 during their post-action phase. 

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