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A generic drug is a copy of a brand name drug. It works the same as the brand name drug.
• The FDA requires that all drugs are safe and effective. Generic drugs use the same substances and work the same way in the body as brand name drugs. So they have the same risks and benefits as the brand name drug.
• The FDA demands that generic drugs are just as strong, pure, and stable as brand name drugs. They must also be the same quality.
• Generics work in the same way and in the same amount of time as brand name drugs.
• Both brand name and generic drug factories must meet the same standards. The FDA will not let drugs be made in poor quality factories. The FDA inspects about 3,500 factories a year to make sure they meet the standards. Often the same factories make both brand-name and generic drugs.
• In the United States, laws do not allow a generic drug to look exactly like the brand name drug. A generic drug must use the same substances as brand drugs. Colors, flavors, and some other inactive parts may be different.
• Brand name drugs are protected by patent for 20 years. When the patent expires, other drug companies can create generics. But they must be tested by the maker and approved by the FDA.
• Contact your doctor, pharmacist, or insurance company for information on generic drugs.
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Generic Drugs: www.fda.gov/cder/ogd/index.htm
FDA Office of Women's Health: www.fda.gov/womens/
August 2005