first edition (1980) of the Orange Book - FDA Law Blog

and the rate of absorption.pharmaceutical equivalents ofbioequivalent without adequatebeing presented to the agency.FDA does not considerthese products as beingevidence of bioequivalenceBRSuppositories fbr Systemic UseThe absorption of active ingredients fran suppositoriesthat are intended to have a systemic effect (ascontrasted with suppositories administered for localeffect) can vary significantly from product to product.Therefore, FDA ccnsiders pharmaceutically equivalentsystemic suppositories as bioequivalent only if positiveevidence of bioequi valence is available. In those caseswhere PJSi ti ve evidence is available, the product iscoded AB. If such evidence is not available, theproductS are coded BR.BSProducts Having Drug Standard DeficienciesIf the drug standards for an acti ve ingredient in aparticular dosage form are found by FDA to be deficientso as to prevent an FDA evaluation of either pharmaceuticalor therapeutic equivalence, all drug productscontaining that active ingredient in that dosage form arecoded BS. For example, if the standards permit a widevar iatlcii. in pharmacologically active compcnents of theactive ingredient such that pharmaceutical equivalence isin questicn, all products containing that active ingredientin that dosage form are coded BS.BXInsufficient DataThe code BX is assigned to specific drug products forwhich the agency has insufficient data to determine thetherapeutic equivalence status under the policies statedin this docunent. In these situaticns the drug productsare presumed to be inequivalent until adequate informationbeoames available to make a full evaluaticn oftherapeutic equivalence.I - 16