My understanding is that the TMax issue that Elite and Purdue came upon recently- was not really an issue two years previously - and that after the FDA told Elite not to worry about the TMax situation bc it was a labeling issue..........then changed their mind in relation to all the IR overdoses that was happening in this country.
I don't think the issue is solely focussed on Elite........I think the FDA raised the bar for all pharmaceutical companies trying to formulate IR drugs.