A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product.
- Browse Related Terms: Brand Name Drug, Chemical Type, Dosage Form, Drug Product, Generic Drug, Medication Guide, New Molecular Entity (NME), Over-the-Counter Drugs (OTC), Patient Package Insert (PPI), Pharmaceutical Equivalents, Prescription Drug Product, Strength, Therapeutic Equivalence (TE), Therapeutic Equivalence (TE) Codes
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