Fast Five Quiz: Generic Medications

Mary L. Windle, PharmD


November 22, 2019

The FDA's Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a free online resource that allows practitioners to evaluate generic medications. Medications are coded by level of therapeutic equivalence with the brand-name agent, allowing for quick comparisons. For example, a code of "A" is assigned to generic medications that are bioequivalent to the brand-name drug; a code of "AB" suggests that an agent may have slight, albeit nonmedically significant, differences in bioequivalence; and a code of "B" indicates inequivalence. When consulting the Orange Book, it is important to keep in mind that this publication only provides comparison data between a brand-name drug and its generic counterpart(s) and does not provide generic-to-generic drug comparisons.

The FDA package insert, or prescribing information, does not provide comparison data between a branded drug and its generic counterpart(s).

The FDA's Office of Device Evaluation (ODE) Guidance Memoranda, commonly known as the Blue Book Memos, provide information to help manufacturers understand the ODE regulations and guidelines, including biocompatibility information, for medical devices.

Although the Physicians' Desk Reference provides information (ie, package inserts) about commercially available drugs, it does not provide comparison data between a branded drug and its generic counterpart(s).

Access the FDA Orange Book here.


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