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

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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
G. DESCRIPTION OF SPECIAL SITUATIONSCertain drugs present special situatioos that deserve a IYOre completeexplanatioo than can be provided by the two-letter codes used in the List.These drugs have particular problems wi th standards of identity, analyticalmethodology, or bioinequivalence that are in the process of resolutioo. Thefollowing are in this category:1. Chlorothiazide Tablets, 500 mg. - The agency has identified a batchto batch variability problem with currently approved brands of chlorothiazide500 mg. tableted products. In additioo, there is evidence thatthis tablet dosage form is not proportional in dosage to the 250 mg.tablet. Firms with awroved 500 mg. products and FDA are Carrying outstudies to resolve this matter. These products are coded BD.2. Conjugated Estrogen and Esterified Estrogen Tablets - Data havebeen sutmi tted to FDA indicating that there are significant differences inblOJd levels of the active ingredients produced by different conjugatedestrogen tablets. These differences could affect therapeutic activity.They are believed to be directly related to the wide range of differencespermitted by the current official standards in the several active estrogenicsteroids in conjugated estrogen products. Because of the wide range of thesame active estrogenic steroids in esterified estrogens, this same coocernextends to these products as well. FDA is w:>rking with the USP to revisethe standards of identity for coojugated and esterified estrogens. Untilsoch time as the standards issue is resolved, however, FDA is tmable tocooclude that coojugated estrogen or esterified estrogen tablets produced bydifferent manufacturers are necessarily pharmaceutical equivalents. Theseprodoc ts have thus been coded BS.3. Erythromycin (base) Tablets - All manufacturers of erythromycinbase tableted prodocts demonstrated the bioavailability/bioequivalence oftheir products as a conditioo of awlicatioo approval. At the time ofinitial approval all such products were tested under fasting conditions and,as a result, all firms were required to label their products to be takenonly under fasting condi tioos. Since that time, at least one firm hassubstantially revised its product so that it also produces satisfactoryblood levels in the presence of food. Thus, the physician and pharmacistmust be alert to labeling differences between erythromycin products withrespect to administratioo in the presence of food.In additioo, FDA has received new data which deIIlCnstrate theinequivalence of sane erythromycin base tablets 00 a fasting basis. Untilthis matter is resolved, all erythr~mycin base tablets have been coded BX.I - 17
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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