Legal Definitions - Approved Drug Products with Therapeutic Equivalence Evaluations

Approved Drug Products with Therapeutic Equivalence Evaluations is also known as the Orange Book. It is a publication by the US Food and Drug Administration (FDA) that lists all approved drug products and their therapeutic equivalence evaluations.

For example, if a drug has a generic version, the Orange Book will list both the brand name drug and the generic drug, along with their therapeutic equivalence ratings. This rating system helps healthcare providers and patients determine if a generic drug is equivalent to its brand name counterpart in terms of safety and effectiveness.

The Orange Book is an important resource for healthcare providers, pharmacists, and patients to make informed decisions about drug therapy. It helps ensure that patients receive safe and effective medications, while also promoting competition and cost savings in the pharmaceutical industry.