Final answer:
The FDA Orange Book uses a therapeutic equivalence codes system to indicate whether generic drugs are equivalent to brand-name drugs. The 'A' codes show equivalence and interchangeability, while 'B' codes indicate non-equivalence. An 'AB' rating specifically denotes bioequivalence according to the FDA.
Step-by-step explanation:
The FDA Orange Book utilizes a coding system to classify the therapeutic equivalence of generic drugs. This system involves therapeutic equivalence codes, which indicate whether the generic drug is equivalent to the brand-name reference listed drug. These codes consist of an alphabet letter followed by a number. The most frequently encountered codes are A codes, which signify that the FDA has determined the generic medication to be therapeutically equivalent to and interchangeable with the branded medication. Conversely, B codes denote that the generic drug is not considered to be equivalent.
For example, an AB rating indicates that the FDA has judged the generic drug to be bioequivalent to the branded drug, while a B code without a corresponding A rating would indicate certain deficiencies or differences that prevent the FDA from deeming it equivalent. This coding system plays a crucial role in ensuring that patients receive drugs that perform therapeutically as expected, thereby maintaining both safety and effectiveness standards.