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

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4. Erythromycin stearate Tablets - All manufacturers of erythromycinstearate tableted products demonstrated the bioequivalency of their productsas a conditien of applicatien approval. These bioequivalence studies wereperformed under fasting conditions and, as a result, all firms were requiredto label their products to be· taken en an empty stomach. Since that timesane firms have demonstrated that their products also may be taken immediatelybefore meals, but not with meals, and still achieve acceptable bloodlevels. On the basis of such studies, FDA has approved those products to belabeled accordingly. At the ·same time, the agency stresses that optimalabsorption for any erythromycin stearate tablet is achieved when the drug isadministered under fasting conditiens, and recorrmends that prescriptionsinclude instructions regarding administratien in relation to meals. Whenerythromycin stearate tablets are to be administered under fasting conditions,the agency believes that any listed brand coded AB may be consideredtherapeutically equivalent. If erythromycin stearatE! is to be takenimnediately before meals, only those products with labeling that providesfor such administratien should be dispensed. Erythromycin stearate tabletedproducts have been designated therapeutically equivalent (AB) in the Listbecause all of the products produce equivalent blood levels provided thedrug is prescribed and administered in accordance with the conditions of usein the labeling. Prescribers and dispensers are advised to be familiar withthe labeling of these products.5. Imipramine HCI Tablets - The agency has determined that certainbrands of imipramine tablets may undergo deterioration in their dissolutionrate as the tablets age on the shelf, even under normal conditions ofstorage. FDA will be proposing to the USP a new dissolutien rate standardto solve this problem. Those products that already meet the proposed newstandard are coded AB. Products without data to support satisfactorydissolution are coded BP.6. Amino Acid and Protein Hydrolysate Injections - Of these tWo typesof products, only parenteral amino acid mixture solutions presently arelisted as approved and marketed under new drug applicatiens. Proteinhydrolysate injections. are omitted because of safety problems. Becausethese products differ by the amount and kinds of amino acids they contain,tooy are not considered pharmaceutical equivalents. Thus, it is on thisbasis that FDA cannot evaluate these products as therapeutic equivalents.At the same time, the agency believes that it is appropriate to point outthat where nitrogen balance is the sole therapeutic objective and individualamino acid content is not a consideration, pharmaceutical alternativeproducts with the same total amount of nitrogen content may be considered astherapeutically equivalent.7. Prednisone Tablets - Because of known bioinequi valence and ther apeutic inequivalence problems, the USP recently adopted a new in vitrodissolution test correlated with in vivo bioequivalence data. All prOductsI - 18
have been subject to a voluntary batch-to-batch certificatioo program overthe last year to assure that products are in compliance with the USPdissolutioo requirement. Based 00 in vivo studies, FDA has published aproposal to establish the USP dissoluTIoo requirement as the bioequivalencerequirement for prednisone tableted products. Determination of therapeuticequivalence for prednisone table ted products will be made after the evaluatimof cornnents 00 that proposal. Until then, all prednisone products arecoded BX.8. Prednisolone Tablets Al though FDA-spoosored biopharrnaceuticstudies of prednisolone tablets have not revealed product bioinequivalence,a deterrninatim of the therapeutic equivalence of prednisolone tablets willnot be made at present because of the close similarities between prednisoleneand prednisone. Based en in vivo and in vitro studies, FDA haspublished a proposal to establisn t'fie"""" dissolutim requirement as thebioequivalence requirement for prednisolone tableted products. As withprednisone, determinatim of therapeutic equivalence will be made afterevalua tim of comnents m this proposal. Until then, all prednisoleneprodocts are coded BX.H. QPDATING~FDA will provide per iodic supplements furnishing, arncng other things,new drug approval information and, if necessary, revised therapeutic equivalenceevaluatims. The supplements will be provided l101thly, at leastduring the first year after the List is published. All parts of thisdocument - the preface and the listings - will be subject to any changes andadditions made in the suwlements. A complete updated List will be published00 an annual basis, and each subscr iptioo will include all per iodicsuwlements in a given year.I - 19\
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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