FDA approves new version of OTC metered-dose inhaler for mild asthma

FDA approved this week epinephrine inhalation aerosol bronchodilator suspension (Primatene Mist—Amphastar Pharmaceuticals) for "temporary relief for symptoms of mild, intermittent asthma." The OTC metered-dose inhaler uses hydrofluoroalkane propellants, which are permitted under current international and U.S. law.

FDA approved this week epinephrine inhalation aerosol bronchodilator suspension (Primatene Mist—Amphastar Pharmaceuticals) for "temporary relief for symptoms of mild, intermittent asthma." The OTC metered-dose inhaler uses hydrofluoroalkane propellants, which are permitted under current international and U.S. law. The former OTC Primatene Mist was taken off the market 7 years ago because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. FDA said the OTC drug "is approved only for those who have been diagnosed with asthma by a health care provider. Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional." In announcing the product's approval on Thursday, FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research, noted they have taken steps to make sure the OTC inhaler was used safely. "In the OTC space, it's always important that the consumers understand how to safety and effectively use a new product. The scientific information we reviewed to approve the new version of OTC Primatene Mist shows there is a narrow population of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler." They said it is important to ensure that patients can understand and apply the instructions for use, that the inhaler only be used for those with a diagnosis of mild, intermittent asthma, and that patients know "to seek medical care if the patient is using it regularly, as overuse of the product is a risk." Patients who are interested in the new version of the inhaler should not stop taking their current asthma treatment without discussing it with their health care provider first. The new product also looks different from the old version, and it has updated instructions for use that must be followed for the inhaler to work correctly.