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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