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

approved application, a list of application holders including an abbreviatedname designation, and an appendix of drug products still being evaluated foreffectiveness in the Drug Efficacy study Implementation (DESI) program.A complete discussion of the background and basis of FDA's therapeuticequivalence evaluation policy was p..1blished as a proposal in the FederalRegister on January 12, 1979 (44 FR 2932) . The final rule, which includesFDA's responses to the p..1blic comnents rece i ved on the proposal, wasrecently published in the Federal Register.B. DEFINITIONSApproved Prescription Drug Products - This term refers to currentlymarketed prescription drug products approved by FDA through new drugapplications (NDA's) or abbreviated new drug applications (ANDA' s) under theprovisions of section 505 of the Federal Food, Drug, and Cognetic Act (theact) or, in the case of antibiotics, through analogous applications known asForms 5 or Forms 6 under section 507 of the act. All drug products on theList have been fully reviewed and awroved for safety and effectiveness byFDA. The law also permits drugs to be legally marketed without such fullyapproved applications under certain circumstances, but the drugs so marketeddo not appear on the List. They consist primarily of: 1) drugs marketedprior to 1938 that are rot subject to the pre-market clearance procedures ofthe law, and 2) drug products marketed between 1938 and 1962 that wereapproved for safety but rot effectiveness ("deemed awroved") and are stillbeing reviewed under the administrative procedures of the Drug EfficacyStudy Implementaticn (DESI) program. The drug products still in the DESIadministrative process are listed in an awendix to the List.Pharmaceutical Equivalents Drug products are considered to bepharmaceutical equivalents if they contain the same active ingredients andare identical in strength, dosage form, and route of administration (e.g.,chlordiazepoxide HCl, 5 mg. capsules, made by tVXl or more different manufacturers). pharmaceutically equivalent drug products, sometimes calledchemical equivalents, are formulated to contain the same amount of activeingredient in the same dosage form and to meet the same or comparablestandards (i.e. identity, strength, p..1rity and quality), but they may differin characteristics such as color, taste, shape, packaging, expiration time,and, within ce,ttain limits, labeling.Pharmaceutical Alternatives - Drug products are considered to bepharmaceutical alternatives if they contain the same therapeutic moiety butdiffer in the salt or ester of that moiety or in the dosage form or strengthI - 3