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In the FDA’s Orange Book, a generic product is considered therapeutically equivalent to its brand-name counterpart when it has a rating of “AB”. [1]
Orange Book rating codes describe how the generic compares to the reference listed drug (the brand) for purposes of therapeutic equivalence, based on FDA-reviewed evidence such as bioequivalence (and, when relevant, additional therapeutic considerations). [1]
To confirm therapeutic equivalence for a given medication, look up the brand and generic(s) in the FDA Orange Book and check the rating column for the generic’s entry. If it shows AB, it means the generic is therapeutically equivalent to the reference listed drug. [1]
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