News & Views

FDA Approves Primatene® MIST

For temporary relief of mild symptoms of intermittent asthma

The makers of Primatene® MIST, Amphastar® Pharmaceuticals, Inc., announced on November 7, 2018 that the asthma inhaler remembered by many in the asthma community for more than 50 years has been approved by the Food and Drug Administration (FDA). Primatene® MIST is now the only FDA-approved asthma inhaler available without a prescription in the United States.

Provides new, user-friendly features

Primatene® MIST is made for the temporary relief of mild symptoms of intermittent asthma in people ages 12 and above. It is not intended for people with moderate or severe asthma.

Primatene® MIST now features:

  • A patented formulation with epinephrine as the active ingredient
  • A non-chlorofluorocarbon (CFC) propellant called hydrofluoroalkane (HFA)
  • A built-in spray indicator
  • A pressurized metal canister
  • Updated instructions for use and cleaning

Meets environmental standards

The original Primatene® MIST was removed from the market in 2011 because it used CFCs to move the medicine out of the inhaler. CFCs deplete the earth’s ozone layer. When the United States signed the Montreal Protocol on Substances that Deplete the Ozone Layer, participating countries agreed to phase out products that use CFCs. Now that the reformulated Primatene® MIST has replaced CFCs with HFAs and has received FDA approval, the asthma inhaler is once again available as an over-the-counter option for temporary relief of mild symptoms of intermittent asthma.