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You know that question that goes through your mind when you
take your generic drug?
Here's the answer.
What is a generic drug?
When a brand-name drug's patent protection expires, generic
versions of the drug can be approved for sale. The generic version works like
the brand-name drug in dosage, strength, performance and use, and must meet
the same quality and safety standards. All generic drugs must be reviewed and
approved by FDA.
How does FDA ensure that my generic drug is as safe
and effective as the brand-name drug?
All generic drugs are put through a rigorous, multi-step
review process that includes a review of scientific data on the generic drug's
ingredients and performance. FDA also conducts periodic inspections of the
manufacturing plant, and monitors drug quality – even after the generic drug
has been approved.
If generic drugs and brand-name drugs have the same
active ingredients, why do they look different?
Generic drugs look different because certain inactive ingredients, such as
colors and flavorings, may be different. These ingredients do not affect the
performance, safety or effectiveness of the generic drug. They look different
because trademark laws in the U.S. do not allow a generic drug to look exactly
like other drugs already on the market.
Is my generic drug made by the same company that makes the brand-name drug?
It is possible. Brand-name firms are responsible for
manufacturing approximately 50 percent of generic drugs.
Are generic drugs always made in the same kind of
facilities as brand-name drugs?
Yes. All generic drug manufacturing facilities must meet
FDA’s standards of good manufacturing practices. FDA will not permit drugs
to be made in substandard facilities. FDA conducts about 3,500 inspections a
year to ensure standards are met.
FDA makes it tough to become a generic drug in America so
you can feel confident about taking your generic drugs. If you still want to
learn more, talk with your doctor, pharmacist or other health care
professional or call 1-888-INFO-FDA.
Generic Drugs: Safe. Effective. FDA Approved.
Consumer Education: Generic Drugs
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FDA/Center for Drug Evaluation and Research
Last Updated: August 17, 2005
Originator: OTCOM/DPA
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