8 November 2018 - Deborah Wilkes
The US Food and Drug Administration (FDA) has approved a new version of Primatene Mist (epinephrine) seven years after the OTC asthma inhaler was taken off the market.
Amphastar Pharmaceuticals said the new OTC Primatene Mist would be available in drugstores across the US in early 2019.
The company pointed out that Primatene Mist was the "only FDA-approved asthma inhaler available without a prescription in the US".
Amphastar’s chief executive officer, Jack Zhang, said the company was "grateful to the FDA team for working closely with us to make this approval possible, recognising the important role of OTC bronchodilator drugs such as Primatene Mist".
Original used CFC propellants
The original OTC Primatene Mist was phased out in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer.
The new version contains hydrofluoroalkane propellants, which are permitted under current international and US law.
Primatene Mist has been approved by the FDA for temporary relief of symptoms of mild, intermittent asthma for people aged 12 years and above.
Significant new features
Amphastar said Primatene Mist had a number of "significant" new features including a built-in spray indicator and a metal canister instead of the original glass container. The product delivers 125 microgrammes of epinephrine per actuation compared with 200 microgrammes for the original.
The FDA stressed that OTC Primatene Mist was approved "only for those who have been diagnosed with asthma by a healthcare provider".
"Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a healthcare professional," commented the FDA. "It's important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a healthcare professional."
The regulatory agency noted that when the original OTC Primatene Mist was taken off the market "many people objected to the removal of the product" but some healthcare professionals believed "asthma patients could be harmed by self-medicating with an OTC product". "There were a complicated set of issues informing these differing views," commented the FDA.
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