After seven years off the market, the FDA has cleared a new version of Primatene Mist as an over-the-counter treatment to provide temporary relief for symptoms of mild, intermittent asthma, according to an agency statement.

The drug is approved only for those who have been diagnosed with asthma by a healthcare provider and is not a replacement for prescription asthma treatments, the FDA noted.

According to a published Q&A with the FDA, the new version is approved for use in people ages 12 years and older.

“Do not use this medicine in children younger than 12 years. It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and up,” said Theresa Michele, MD, director of the FDA’s Division of Nonprescription Drug Products, CDER.

According to Michele, Primatene Mist can be used for temporary relief of mild [sic] symptoms of intermittent asthma, including wheezing, tightness of the chest, and shortness of breath. “If your asthma is not better within 20 minutes of use, if it gets worse, if you need more than eight inhalations in a 24-hour period, or if you have more than two asthma attacks in a week, see a doctor right away,” Michele said, noting these could indicate worsening asthma or an impending exacerbation.

The FDA noted that a former version of OTC Primatene Mist was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. This new version contains hydrofluoroalkane propellants, which are permitted under current international and US law and used in some prescription inhalers, the FDA said.


More information on Primatene Mist is available via the FDA.