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.

Mar 4, 2025 · On Monday, the FDA approved the first generics of Xarelto (rivaroxaban), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery …

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.

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 …

Dec 20, 2024 · Join us at the annual Generic Drugs Forum, a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generics.

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.

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

By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. In 2024, FDA approved 42 biosimilars compared to 110 by the European Medical …