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

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

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 …

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.

Nov 22, 2024 · Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.

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 ...

Oct 17, 2024 · Estimated Savings from Generic Drug Approvals We recognize that there has been increasing attention on whether the lower cost of generic drugs, especially as more …

Oct 10, 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.

Mar 4, 2024 · Our 2023 Annual Report provides highlights of activities and accomplishments including generic drug approvals, first generic approvals, science and research innovations for …

Mar 21, 2025 · FDA develops resources – workshops, webinars, and seminars – to help generic drug manufacturers improve the quality of their abbreviated new drug application (ANDA) …