The FDA this week approved Amphastar Pharmaceuticals‘ (NSDQ:AMPH) over-the-counter Primatene Mist inhaler for the temporary relief of mild symptoms of intermittent asthma. The original version of Amphastar’s Primatene Mist device was taken off the market in 2011 because it contained chlorofluorocarbon propellants – a chemical compound that is linked to depletion of the Earth’s ozone […]
Amphastar Pharmaceuticals
Primatene Mist Inhaler rejected by FDA
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 Amphastar’s subsidiary, Armstrong Pharmaceuticals, that the company needs to change the inhaler’s label and packaging. The FDA also recommended that the company […]
