I was oversimplifying, but yes the manufacturer still has to prove that their drug is equivalent to the gold standard for therapeutic uses and that they have su

I was oversimplifying, but yes the manufacturer still has to prove that their drug is equivalent to the gold standard for therapeutic uses and that they have sufficient quality control. How much it costs depends on the complexity of the drug and who does it. An experienced generic drug manufacturer will have everything in place for patient selection, investigators on their payroll, and expertise in designing protocols for the marketing application. Since we're talking about adrenaline, not some complex drug cocktail, I think the device portion would make up the majority of the cost (life and death emeregency device + has to work in the field without a medical professional tends to be pricey).