Primatene MIST (epinephrine inhalation aerosol bronchodilator suspension; Amphastar) is now available over-the-counter (OTC) for the temporary relief of mild symptoms of intermittent asthma (eg, wheezing, tightness of chest, shortness of breath) in patients aged ≥12 years.

The metered dose inhaler, which delivers 0.125mg of epinephrine per spray, was approved by the Food and Drug Administration in November 2018. The approval spurred several asthma and allergy groups to issue a statement expressing concern over the availability of an OTC product for asthma treatment, noting that it could potentially endanger patients.

In a press release, the FDA stated that analysis of the data showed no major safety concerns for patients with mild symptoms of intermittent asthma who choose to use Primatene MIST. Both the Agency and the groups agreed that a healthcare provider should be involved in the management plan of patients with asthma.

The Primatene MIST inhaler contains 160 metered sprays and is available nationwide at Walgreens stores and online at Walgreens and CVS; it will be available nationwide at CVS stores by mid-January. The product is expected to be available in more stores in the coming months.

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