Generic drugs Equivalence Evaluations

Generic products tested by the FDA and determined to be therapeutic equivalents are listed by the FDA in their publication Approved Drug Products with Therapeutic Equivalence Evaluations. These products contain the same active ingredients as their brand-name counterparts and also meet bioequivalence standards. The FDA recommends substitution only among products listed as therapeutically equivalent. 

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, Electronic orange book Approved drug products with therapeutic equivalence evaluations, available http //www.fda.gov/cder/ob/default.htm, accessed Apr. 21, 2005. 

Bioequivalence studies are the basis for determination of the therapeutic equivalence between a pharmaceutically equivalent generic drug product and a corresponding reference hsted drug. This hst is provided in the book titled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. °... 

---