A BX generic indicates what about data?

• A. Data is insufficient to determine therapeutic equivalence
• B. Equivalent classification by FDA
• C. Bioequivalence problems documented
• D. Not approved for use

Answer: (A)

Therapeutic equivalence codes summarize if a generic product can be substituted for a brand with similar clinical effect. The two-letter code on the FDA’s labeling indicates two things: whether the products are pharmaceutically equivalent and whether bioequivalence has been demonstrated. When the second letter is X, it signals that there isn’t enough data to determine bioequivalence, so therapeutic equivalence hasn’t been established. Therefore, a BX designation means the available data are insufficient to conclude therapeutic equivalence.