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For nearly two decades, America’s generic pharmaceutical industry has been developing, manufacturing and marketing bioequivalent generic versions of brand prescription drugs. These generic products have been used by millions of American consumers, and offer the same safety and effectiveness as their brand counterparts.

In order to be deemed therapeutically equivalent to brand products, generic drugs must have the same active ingredients, same dosage form, same standards for purity and quality, same standards for manufacturing, and same amount of drug absorbed over the same time as the equivalent brand product. Generics are also required to meet the same stringent government standards for strength, purity and potency as the brand version.

The Food and Drug Administration (FDA) has repeatedly affirmed that the generic approval process is as rigorous and thorough as the process by which brand drugs are approved. When a generic drug receives FDA approval, research and clinical experience indicates that the generic drug is not only bioequivalent but also clinically equal to and as safe and effective as the brand name drug it is a copy of.

In order to market a generic equivalent to a brand pharmaceutical company’s drug product (once the market exclusivity on the innovator’s product has expired), a generic pharmaceutical company uses the Abbreviated New Drug Application (ANDA) process of the FDA.

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