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

that are pharmaceutical equivalents are labeled by theirdifferent application holders for different routes ofadministration. Injectable products available as drypcMders for reconstitution, concentrated sterile solutionsfor dilution, or sterile solutions ready forinjection, are all considered to be pharmaceutically andtherapeutically equivalent provided they are designed toproduce the same concentration for injection and areequivalently labeled. Consistent with accepted professionalpractice, it is the responsibility of the prescriber , dispenser, or individual administering theproduct to be familiar with a product's labeling toassure that it is given only by the route(s) ofadrrdnistration stated in the labeling.Certain corrmonly used large volume intravenous productsare not included on the List (e.g., dextrose 5% withwater, dextrose 10% with water, sodium chloride 0.9%injection). Virtually all of these drug products came onthe market in glass containers before 1938 and have notbeen required to obtain an approved new drug applicationas a condi tion of marketing. When packaged in plasticcontainers, however, these same drug products areconsidered to be ntw drugs requiring atproved new drugapplications for marketing. All large volume parenteralproducts are manufactured under similar standards,regardless of whether they are packaged in glass orplastic. Thus, FDA has no reason to believe that thepackaging container of large volume parenteral drugprodocts that are pharmaceutically equivalent would haveany effect on their therapeutic equivalence.ATTopical ProductsThere are a variety of dosage forms available fortopical, ophthalmic, otic, rectal arrl vaginal administration,including solutions, creams, ointments, gels,lotions, pastes, sprays, and same sUfPOsitories. Differenttopical dosage forms are not pharmaceuticallyequivalent even though they may contain the same active.ingredient, and, therefore, they are not consideredtherapeutically equivalent. Products in the same topicaldosage forms are, however, in the absence of contrarydata, considered therapeutically equivalent if they arepharmaceutically equivalent.I - 13