The United States Food and Drug Administration (FDA) uses a code to indicate the therapeutic equivalence of a medication. This is utilized in its "Orange Book" of Approved Drug Products.
Group
Bioequivalence Relative to Other Pharmaceutically Equivalent Drug Products
A
no problem with bioequivalence, with or without equivalence studies (includes situations where none are known or suspected)
B
problem with bioequivalence
Subgroup
Bioequivalence
AA
conventional dosage form NOS, bioequivalence not a problem
AB
meets bioequivalence requirements (demonstrated)
AN
nebulizer or aerosol, bioequivalence not a problem
AO
oil preparation for injection, bioequivalence not a problem
AP
parenteral drug (injactable, typically aqueous), bioequivalence not a problem
AT
topical preparation, bioequivalence not a problem
where:
• All oral drugs are submitted for some form of bioequivalence assessment.
Group
Bioequivalence
BC
problem with bioequivalence, extended-release preparation (oral or injectable)
BE
problem with bioequivalence, delayed-release oral preparation
BN
problem with bioequivalence, nebulizer or aerosol
BR
problem with bioequivalence, rectal or suppository preparation
BS
problem with bioequivalence, related to deficiencies in the drug standard
BT
problem with bioequivalence, topical preparation
BD
problem with bioequivalence, documented
BP
problem with bioequivalence, potential
BX
problem with bioequivalence, information insufficient
B*
problem with bioequivalence, drug withdrawn
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