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  1. Generic Drug Facts | FDA

    Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.

  2. Generic Drugs: Questions & Answers | FDA

    Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.

  3. This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications ...

  4. Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly clinical ...

  5. Office of Generic Drugs 2022 Annual Report | FDA

    In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally less expensive ...

  6. First Generic Drug Approvals | FDA

    Oct 23, 2025 · “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States.

  7. This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications ...

  8. Biosimilars Basics for Patients | FDA

    Biosimilars are safe and effective medications for treating many illnesses such as arthritis and cancer. Learn about biosimilars and how they benefit patients.

  9. Generic Drugs | FDA

    Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.

  10. FDA List of Authorized Generic Drugs

    The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand name drug ...