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

B - Drug products that FDA does not at this time consider to be therapeuticallyequivalent to other pharmaceutically equivalent products.Certain multisource drugs awearing on the List have beenclassified with .a "B" code for a variety of reasons. Those drugs thathave been identified ~ the agency as having potential or actual bioinequivalenceproblems and for which adequate studies denmstrating thebioequivalence of the particular product have not been submitted to FDAare classified in the "B" category. A "B" evaluatioo generally is aresult of known or potential problems with the specific dosage form forthose active ingredients for which no bioinequivalence problem has beenidentified by the agency. In additim, there are currently a fewproducts for which the standards are inadequate or for which FDA hasinsufficient informatim at the present time to determine if they are,ther apeu ticall y equivalent.The specific coding definitions and };X>licies for the "B" sub-codesare as folloos:BeControlled Release Tablets, Capsules, and InjectablesThese dosage forms are subject to bioavailability andbioequivalence differences, primarily because differentfirms developing controlled release products for the sameactive ingredient rarely employ the same approach toformulating their controlled release products. FDA,therefore, does not evaluate different controlled releasedosage forms containing the same active ingredient inequal strength as bioequi valent unless equi valencebetween individual products has been specifically dernoostratedthrough appropriate bioequivalence studies.Controlled release products for which bioequivalence dataare available have been coded AB.BDActive Ingredient and/or Dosage Forms with DocumentedBioinequivalence ProblemsThe BD code denotes products containing activeingredlents wi th kno.vn bioinequi valence problems, and forwhich adequate studies have not been sutmitted to FDAdemonstrating the bioequivalence of the drug products.Where such studies are available, the product has beencoded AB.I - 14