This has nothing to do with the FDA. The Montreal Accords, a treaty signed by the US, banned CFCs. They had a clear exemption for inhalers, as long as they wer

This has nothing to do with the FDA. The Montreal Accords, a treaty signed by the US, banned CFCs. They had a clear exemption for inhalers, as long as they were necessary. GSK invented a new delivery method. They patented this method. The existence of method made the Montreal Accords now ban CFC based inhalers. The FDA approved the new method (makes sense). It seems like you have an issue with the USPTO or maybe the diplomats who negotiated the Montreal Accords. The FDA wasn't stopping anyone from making generics. Although maybe once a product can no longer be legally sold it is also unapproved. It doesn't really matter which is the case, they weren't the driving force.