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Medical Devices / Submissions and Approvals

FDA Approves Reconfigured OTC Asthma Inhaler

Nov. 13, 2018

FDA Commissioner Scott Gottlieb offered assurances about the agency’s approval of an OTC asthma inhaler that was previously pulled from the U.S. market in 2011.

Amphastar Pharmaceuticals’ new version of OTC Primatene Mist — the only OTC metered-dose inhaler approved in the U.S. — uses the same active ingredient, epinephrine, that was used in the 2011 product taken off the market because it contained CFC propellants that are known to deplete the ozone layer.

The new version contains hydrofluoroalkane propellants that are allowed under U.S. law, Gottlieb said in a joint statement on the combination product with CDER Director Janet Woodcock.

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