It must also meet the same high standards of quality and manufacturing as the brand-name product, and it must be and quality, taken and used in the same way as well. This standard applies to all generic medicines. It must be the same as a brand-name medicine in dosage, form and route of administration, safety, effectiveness, strength, and labeling (with certain limited exceptions). These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.Īt-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.īack to Top How does FDA ensure generic medicines work the same as brand-name medicines?Īny generic medicine must perform the same in the body as the brand-name medicine.

Where can I find more information about generic medicines?Ī generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

How does FDA monitor side effects or safety issues with generic medicines?.

Is a generic of my brand-name medicine available?.What standards must generic medicines meet to receive FDA approval?.Why do generic medicines often cost less than the brand?.Why does a generic drug look different from the brand drug?.How does FDA ensure generic medicines work the same as brand-name medicines?.

Spanish Language version - Medicamentos Genéricos: Preguntas y Respuestas (PDF - 213 KB)

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