Therapeutically equivalent drug definition
Therapeutically equivalent drug means a drug which contains the same active ingredient(s) and is identical in
Therapeutically equivalent drug means a drug that based on FDA’s scientific and medical evaluations is both pharmaceutically equivalent (same active ingredient, dosage form, strength and route of administration) to the brand product and bioequivalent to the brand product. Such a drug is approved under the Federal Food Drug and Cosmetics Act by the Food and Drug Administration (FDA) with an “A” rating in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (Known as the “Orange Book”).