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

To assist the user in relating the name of the firm 00 the productlabel (the marketer) to the awlicatioo holder identified on the List inorder to determine the product's therapeutic equivalence evaluation, thefollowing should be noted. If the marketer is the awlicatioo holder, theawlicatioo holder identified 00 the List is the same as the name of thefirm 00 the product label. If the marketer is related corporately (e.g., asubsidiary) to the awlicatioo holder, that relatiooship is noted 00 theList. If the agency is unaware of a corporate relatiooship between themarketer and the awlicatioo holder, the List identifies ooly the awlicatiooholder. In this case, the List identifies the drug product (which isthe subject of a single awlicatioo) by its generic name if the product isavailable from more than one marketer, and by its brand name if the productis available from ooe marketer ooly.5. Any product on the List is subject at all times to regulatory action.From time to time awroved products may be found to be in violatioo ofme or nore requirements of the Federal Food, Drug, and Cosmetic Act. Insuch circumstances, the agency will oommence awropriate enforcement actionto remove the violative product from the market by voluntary recall orseizure. If the problem leading to the violatioo is continuing, so thatthere exists a risk of future noncomplying prod~cts entering the market, FDAwill undertake steps to eliminate that risk, e.g., by court injunctioo,witl'rlrawal of the awroval of the marketing awlicatioo, or revocatioo ofthe antibiotic certification. Where the violatioo is corrected by removalof the particular batch of the product from the market, no need exists toexclude the product from this List; the awroval continues and other batchesare not affected. Where additiooal preventive actioo is indicated, theagency will utilize awropriate legal procedures to keep the product off themarket. Such regulatory actioo, however, is independent of the inclusioo ofprodu::ts in the List. The sole criterioo for inclusioo of marketed productsin the List is their being the Subject of an awroved awlicatioo. Marketedprodu::ts will not be removed from the List until completion of FDA proceedingsto witl'rlraw awroval of the product under sectioos 505 or 507, asawlicable. FDA believes that retentioo of a violative product 00 the Listwill not have any significant adverse health consequences because otherlegal tools are available to the agency to prevent actual marketing ofviolative products.It should also be noted that when there is a change in the informatioocontained in FDA files cooceming a multiple source drug product that is onthe List, there exists the potential that the drug product will no longermeet the criteria for therapeutic equivalence. as initially evaluated. Inthis instance, FDA will re-evaluate the drug's therapeutic equivalency byaWlying the current informatioo to the criteria for therapeutic equivalence.If the re-evaluatioo reveals that the listed therapeutic equivalenceevaluatioo is· no looger accurate, the evaluation will be revisedaccordingly.I - 8