What You Do Not Know About Generic Drugs

What You Do Not Know About Generic Drugs.

Generic drugs are important options that allow greater access to health care for all Americans. They are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Health care professionals and consumers can be assured that FDA approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity and stability as brand-name drugs. And, the generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs. Generally, generic drugs sell at lower prices, and it is in the public’s interest to get generic drugs to the market quickly.  But, like any other scientific and regulatory process, approval of a generic drug takes time.  It takes FDA time to review the complex information needed to demonstrate that a given generic drug can be substituted for the brand-name drug that it copies, and that time also depends on the complexity of the drug product and the completeness of the application. But the outcome of certain generic drug reactions may not square with reality in the experience of some consumers. Credit: U.S. Food & Drug Administration.

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