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

posi tive evidence of bioavailabili ty is necessary, are shavn to be bioequivalentto an awropriate standard. The agency believes this policy iscoosistent with the prevailing opinioo of experts and with general experiencein the marketplace through the years.The agency has coosidered, and rejected, the optioo of requiringin vivo bioavailabili ty stu::Hes for every product. Such a policy v.ouldresul t in the testing in hunans of a large number of products for whichthere is 00 evidence of a bioavailabili ty problem, and \',()uld thereby wastethe nation's clinical research resources 00 the repeti ti ve testing of drugproducts for little or 00 scientific purpose. For this reason, FDA haselected under its bioavailability and bioequivalence regulations to confinein vivo testing of products for bioavailabili ty to those particular drugsror~ich such testing is scientifically and medically necessary. Incoosidering the therapeutic equivalence of drugs with known or potentialbioavailability problems, the agency has followed a policy of evaluating astherapeutic equivalents rnly those products that have met current requirements(in vivo testing in hunans, in vitro dissolutioo rate requirements, orboth, aepending 00 the drug). -When bioavailability or bioequivalencerequirements are newly established, there is a transitioo period duringwhich all manufacturers are required to sul:rni t informatioo regarding theirproducts. For this reasoo sane manufacturers whose products may not haveyet met the requirement are still legally marketed.The agency has excluded from the List those products that are knavn tobe 00 looger marketed. Approved products row regarded as medical devices,biologics, or foods are also excluded from the List. In addition, approveddrug products solely marketed abroad are excluded.D. I.EX;AL STA'IUS OF THE LISTThe Approved Prescriptioo Drug Products list contains only publicinformatioo and advice. The List is not a recomnendatioo as to which drugproducts persoos should purchase, prescribe, dispense, or conversely, whichprodocts should be avoided. It dces not impose any requirement or restrictimupcn any person. TO the extent that the List identifies drug productsapproved for marketing under sectioos 505 and 507 of the Federal Food, Drug,and Cosmetic Act, it merely sets forth information to which the public isentitled under the Freecbm of Information Act. Exclusion of a drug productfrom the List