The FDA met yesterday to discuss whether or not to approve Primatene Mist for asthma.
Primatene Mist used to be an over the counter inhaler (epinepherine) for asthma. With government regulations on CFC’s it went off the market as the manufacturer needed to reformulate the product. The advisory committee advised against approving it again as a lot of concerns were brought up regarding this medication. My most important concern would be that many patients would be self diagnosing themselves with asthma without seeing medical support. Even amongst doctors, Primatene Mist is never prescribed as a rescue inhaler, as there better alternative medications, i.e. Albuterol. The decision is not final, but likely we will not see this medication on the pharmacy shelves in the near future.
Once again the FDA did not approve Primatene Mist this time by Amphastar Pharmaceuticals. The FDA asked for further changes to the label and packaging and asked for another validation study. CEO Jack Zhang plans to continue to work with the FDA to get Primatene Mist available to consumers OTC, although it is not looking good so far.