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

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an evaluatien of therapeutic equivalence is assigned to pharmaceuticalequivalents enly if the approved New Drug Application contains adequatescientific evidence supporting the bioequivalence of the product to aselected standard product. This evidence may be an in vivo bioavailabilitystudy or an in vitro dissolutirn rate study orboth, dependingupoo the drug.There are some general principles which may affect the substitutionof pharmaceutically equivalent products in same specific cases.Prescribers and dispensers of drugs should be alert to these principlesso as to deal appropriately with situations which require professionaljudgment and discretirn.1. There may be labeling differences among pharmaceuticallyequivalent products which require attentien on the part of thehealth professional. For example, pharmaceutically equivalentpcMders to be reconstituted for administration as oral orinjectable liquids may vary with respect to their expirationtime or storage conditions aft~r reconstitution. An FDAevaluatirn that such products are therapeutically equivalentis applicable enly when such products are reconstituted,stored, and used under the conditions specified in thelabeling of each product.2. Occasirnally there may be variations among pharmaceuticallyequivalent products in the labeling instructions en doseand administratirn. For example, a particular brand of anantibiotic might require administration rn an empty stomach,while another brand might permit administration without regardto food intake en the basis of blood level studies done afteradministratien in the presence of food. An FDA evaluation oftherapeutic equivalence in such cases is applicable only whensuch products are taken in accordance wi th labeling directionsfor the particular product.3. In some cases closely related products are listed ascontaining the same active ingredients but in somewhatdiffering amounts. In determining which of these products arepharmaceutically equi valent, the agency has employed acriterien that products with labeled strengths of an ingredientthat do not vary by more than 1% will be consideredpharmaceutically equivalent.4. Different salts and esters of the same therapeutic rroietyare regarded as pharmaceutical alternatives. Such productsare rot considered to be therapeutically equivalent. ThereI - 10
known instances in this List where pharmaceuticalalternatives are coded as therapeutically equivalent.Anhydrous and hydrated entities are not considered as pharmaceuticalequivalents unless they meet the same standards and,as in the case of ampicillin, their equivalence is supportedby appropriate bioavailability/bioequivalence studies wherenecessary.5. Drug products that are solids for reconstitutioo, dilutedsolutions, or concentrated solutioos, and that contain differentconcentrations of active ingredients, are not consideredpharmaceutical equivalents. Of course, the exercise ofaccepted professional practice may render pharmaceuticallydifferent coocentrations into pharmaceutical equivalents(e.g., concentrated solutions may be diluted to lowerstrengths by using proper procedures designed to maintain thequality of the product).6. Where package size var iations have therapeutic implications,prodocts so packaged have not been coosidered pharmaceuticallyequivalent. For example, some oral ~traceptivesare supplied in 21- and 28-tablet packets; the 28-tabletpackets contain 7 placebo or iron tablets. These two packagingconfigurations are not regarded as pharmaceuticallyequi valent; thus they are not designated as therapeuticallyequivalent.The specific sub-codes for those drugs evaluated as therapeuticallyequivalent and the policies underlying these codes are listed below:M Products Not Presenting Bioequivalence Problems, InConventional Dosage FormsProducts coded as M are standard formulations of thoseactive ingredients that are not regarded as presentingei ther actual or potential bioequi valence problems. Inaddition, the drug produ:::ts of the active ingredient aremanufactured in dosage forms not presenting bioequivalenceproblems, such as plain tablets, capsules, solutions,elixirs, syrups, and tinctures.ABProducts Meeting Necessary Bioequivalence RequirementsThe AB evaluation denotes products that contain an activeingredient in a dosage- form that is subject to a bioequivalencerequirement, or for which the sul::.missioo of/I - 11
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
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