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FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Amphastar Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is the only FDA-approved asthma inhaler available without a prescription in the United States. Primatene Mist is indicated for the temporary relief of mild symptoms of intermittent asthma in people ages 12 and above.

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