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

Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.

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 name drug ...

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 ...

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 disease (CAD) …

FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. About 9 in 10 prescriptions filled in the U.S. are for generics.

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 generic …

Aug 6, 2025 · About This Workshop The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on …

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