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When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. This variability can and does occur during manufacturing, for both brand-name and generic medicines. It is important to note that there will always be a slight, but not medically significant, level of expected variability-just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. The FDA Generic Drugs Program conducts a rigorous review to ensure generic medicines meet these standards, in addition to conducting inspections of manufacturing plants and monitoring drug safety after the generic medicine has been approved and brought to market.Ī generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. 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)