The US Food and Drug Administration (FDA) issued a statement in support of their decision, with explanatory and cautionary information. At the same time, a joint statement against the approval was issued by multiple asthma patient advocacy groups and community stakeholders saying, in part, that the groups “believe the FDA’s decision endangers people with asthma by suggesting asthma is a ‘do-it-yourself’ disease treatable with OTC medications.”
Back Page: US FDA approves OTC, non-CFC-based Primatene® Mist; Patient advocacy groups object
The approval makes Primatene Mist the only asthma inhaler available in the US without a prescription. However, patient advocacy groups have expressed serious concerns.