FDA rejects Amphastar subsidiary’s Primatene Mist asthma inhaler

Amphastar Pharmaceuticals (NSDQ:AMPH) said this week that the FDA denied its subsidiary’s new drug application for the latest version of its Primatene Mist epinephrine inhaler.

The complete response letter from the federal watchdog told Armstrong Pharmaceuticals that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company conduct another human factor validation study to evaluate consumers’ ability to use the product without the help of a healthcare professional.

Get the full story at our sister site, Drug Delivery Business News.

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