Generic drugs have the same dosage form, safety, strength, route of administration,
and conditions of use as brand-name drugs.
— U.S. Food and Drug Administration
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Fact #1
A generic drug must have the same dosage form, safety, strength, route of administration
and conditions of use as the brand-name product.
Fact #2
The U.S. Food and Drug Administration (FDA) regularly assesses the quality of generic
medications and reports on their performance. The U.S. government strictly regulates
the manufacturing process of all drugs, and all drug manufacturers must meet the
same standards.
Fact #3
A generic drug meets the same stringent performance and bioequivalence standards
set by the U.S. government as the brand-name drugs.
Fact #4
A generic drug is as safe and provides the same therapeutic effects as the brand-name
product for patients of all ages.
Fact #5
Companies that make the brand-name drugs also manufacture many of the generic drugs
approved by the FDA.
Fact #6
Health-care professionals strongly support the use of generic drugs. The American
Medical Association, the largest organization of medical doctors, states that generic
drug products are acceptable for use by the American public. Most hospitals routinely
use generic drugs for treatment of their patients.
Fact #7
The decision to use generic medications is ultimately made through the cooperation
of your physician, your pharmacist and you.
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Myths vs. Reality |
Myth: Generic drugs take longer to act in the body.
Reality: The company seeking to sell a generic drug must show that the drug
delivers the same amount of active ingredients in the same time frame as the original
product.
Myth: Generic drugs are not as potent as brand-name drugs.
Reality: The U.S. Food and Drug Administration (FDA) requires generic drugs
to have the same strength, purity and stability as the brand-name drugs.
Myth: Generic drugs are not as safe as brand-name drugs.
Reality: The FDA requires that all drugs be safe and effective and that their
benefits outweigh their risks. Generic drugs use the same active ingredients and
are shown to work the same way in the body.
Myth: Brand-name drugs are made in modern facilities, and generic drugs are
often made in substandard facilities.
Reality: The FDA won't permit drugs to be manufactured in substandard facilities.
The FDA conducts about 3,500 inspections per year in all firms to ensure standards
are met. Generic drug companies have facilities comparable to those of brand-name
companies. In fact, brand-name drug companies account for an estimated 50 percent
of generic drug production. They frequently make copies of their own or other brand-name
drugs but sell them without the brand name.
Myth: Generic drugs are likely to cause more side effects.
Reality: There is no evidence of this. The FDA monitors reports of adverse
drug reactions and has found no difference in the rates between generic and brand-name
drugs.
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Requirements
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Generic Main Menu
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