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One of the questions I get asked most often, by people outside of the drug industry, is whether generic medications really are the same as the original branded ones. My answer has always been the same: that yes, they are. The higher dose is associated with a risk of seizures, which made the FDA grant a waiver for its testing — they extrapolated from the mg data instead. And right about here is where the red flags began to go up. The agency began to receive reports, almost immediately, of trouble with the mg generic dose. A large number of patients were taking each one, and the number of problems reported could have been explained by the usual variations. The adverse effects e. But they seem to have changed their minds about this. As it turns out, the agency was at that time asking Teva to conduct that missing bioequivalence study with their mg product.
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