Abstract
ABSTRACT In Reply.— The Agency does use the term (not alternates) to refer to different dosage forms of the same active ingredient. (The Food and Drug Administration also uses this term to refer to products that contain the same therapeutic moiety but with different salts of the same active ingredient. This second definition is irrelevant here.) Thus, pancrelipase capsules are considered pharmaceutical alternatives to pancrelipase enteric-coated beads. Two formulations both containing the same amount of active ingredient as enteric-coated beads would be considered pharmaceutical equivalents. They could be rated as therapeutically equivalent if shown to be bioequivalent by an appropriate study.The Food and Drug Administration's Approved Drug Products With Therapeutic Equivalence Evaluations, 10th edition (The Orange Book), lists as therapeutically equivalent erythromycin, delayed-release pellets, oral, 250 mg, from three different manufacturers: Parke-Davis (Morris Plains, NJ), Abbott Laboratories (North Chicago, Ill), and Barr Labs (Pomona, NY). This is so
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