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The FDA Process for Approving Generic Drugs

Generic drugs refer to drugs that are equivalent to brand name drugs. Generic drugs typically cost as much as 80 to 85 percent less than their brand name counterparts but are equally effective. Companies submit an Abbreviated New Drug Application (ANDA) to apply for FDA-approval of a generic drug.

  1. ANDA Facts

    • ANDA data must prove a generic drug is scientifically bioequivalent to the original drug. The generic drug must contain the same active ingredients as the original drug and must be absorbed into the bloodstream at the same rate.

    Features

    • Applications for generic drug approval do not require clinical data that proves the safety and efficacy of the drug, unlike applications for original drugs. This law, established by the Drug Price Competition and Patent Term Restoration Act of 1984, is designed to expedite generic drug availability by making applications less expensive.

    Misconceptions

    • Generic drugs are less expensive than brand name drugs because their manufacturers do not research, advertise or market the drugs. They are not inferior in quality to brand name drugs, according to the FDA.

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