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Primatene Mist FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved November 8, 2018)
Brand name: Primatene Mist
Generic name: epinephrine
Dosage form: Inhalation Aerosol
Company: Amphastar Pharmaceuticals, Inc.
Treatment for: Asthma

Primatene Mist (epinephrine) is an over-the-counter (OTC) bronchodilator used for the temporary relief of the symptoms of mild asthma. The new formulation of Primatene Mist approved November 2018 is a CFC-free metered dose inhaler (MDI) containing hydrofluoroalkane (HFA) propellants.

Why was the original Primatene Mist inhaler taken off the market?
The original version of Primatene Mist available prior to 2011 was an epinephrine metered-dose inhaler that contained chlorofluorocarbon (CFC) propellants. As part of the 1989 Montreal Protocol of Substances that Deplete the Ozone Layer and the Clean Air Act of 1990, all epinephrine inhalers that contained CFCs were phased out of the market.

Directions for Use

Development timeline for Primatene Mist

Nov  7, 2018Approval FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Further information

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