Amphastar announced that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Primatene MIST (epinephrine inhalation aerosol bronchodilator suspension) for the temporary relief of mild symptoms of intermittent asthma (eg, wheezing, tightness of chest, shortness of breath) in patients aged ≥12 years.

Primatene MIST is the only approved asthma inhaler available over-the-counter in the US. It is delivered by a metered-dose inhaler (MDI) with a non-chorofluorocarbon (CFC) propellant. The new patented formulation of Primatene MIST contains the same active ingredient as the original Primatene Mist prior to its withdrawal from the market in 2011 for environmental reasons; the Montreal Protocol treaty had phased out products that contained CFC, which were deemed harmful to the ozone. 

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The new inhalation delivery system no longer includes CFC. It contains hydrofluroalkane (HFA) propellants and also features a built-in spray indicator and metal canister, replacing the glass container seen with the original Primatene Mist. 

Primatene MIST delivers 0.125mg per spray and contains 160 metered sprays. The product is set to launch in pharmacies in early 2019.

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