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 conduct another human factor validation study to evaluate consumers’ ability to use the product without the help of a healthcare professional.
The company’s next-generation Primatene Mist asthma inhaler contains epinephrine as the active ingredient, just like the original Primatene Mist inhaler. The new version of the device does not include chlorofluorocarbons in the delivery system, since CFCs were phased out of products as a result of a global environmental treaty.
The new Primatene Mist inhaler also features a built-in spray indicator and a pressurized metal canister to replace the glass container in the original device.
“While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA during the post-action phase to address their concerns in the CRL by the middle of 2017 and bring Primatene Mist back to the OTC market as soon as possible,” Amphastar CEO Jack Zhang said in prepared remarks.