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 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.
Are the inhalers available through foreign pharmacies? If so, can you specify?
For fifty years Primatene Mist has helped millions, Now with a new propellant, the FDA denies it? Something smells foul with their decision.
Every day I see commercials for new drugs APPROVED by the FDA and 75 percent of the commercial is reserved for the side affects!!! Primatene Mist worked and the government pulled it from the market. So now the only way to get help with asthma is with a prescription. Is there anyone out there who does not believe big Pharma controls the government?
Primitene mist was banned because it worked. Now all we can do is get one bottle a month for 50 bucks of cheap albuterol and it half works. This was all about money and has nothing to do with the environment.
The pharmaceutical manufacturers are a bunch of greedy bastards. They just do not take the public into consideration with development and pricing of medications. The gov’t should introduce a plan of cost plus with a 10% profit margin to make it fair to manufacturers and less costly to the public. The gov’t should give them inducements for R. & D. So that it encourages companies to develop meds for diseases that do not affect the public in large numbers. baltman70@aol.com. Thank you.