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Which orange book rating means a brand and generic drug are therapeutically equivalent?

What Orange Book rating shows a brand and generic are therapeutically equivalent?

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]

What do “AB” and other Orange Book codes mean?

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]

How to verify it for a specific drug

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]

Source

  1. FDA Orange Book (Drug Products with Therapeutic Equivalence Evaluations)


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