PubMed · 9053526
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F Fils. [Substitution].. https://pubmed.ncbi.nlm.nih.gov/9053526/
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The Food and Drug Administration (FDA) is revoking an interim policy statement on inactive ingredients in parenteral, ophthalmic, otic, and topical generic drug products (Interim Inactive Ingredient Policy). These generic drug products are the subjects of abbreviated new drug applications (ANDA's). The Interim Inactive Ingredient Policy was issued as a memorandum from the Acting Director of the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs, FDA, to CDER's Associate Director for Science and Medical Affairs, FDA. FDA is taking this action because the Interim Inactive Ingredient Policy no longer represents current agency policy.
Generics are pharmaceutical products containing the same active substance as an original branded medication. Generics are used in order to reduce the cost of pharmacotherapy. They have to be bioequivalent to the original drug-their mean "area under the curve" (AUC) should not deviate from the AUC of the original by more than 20 per cent. One generic is not necessarily bioequivalent to another generic. It is therefore highly questionable whether an original drug should be replaced by a no-name generic. From a medical point of view only branded generics should be prescribed. "Generics-related" conflicts can be minimized through tight cooperation between hospitals, physicians in ambulatory practice and pharmacies. Generic drugs should never be used if a better but non-generic medication is available.