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.
First Generic Drug Approvals | FDA
Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.
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.
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 …
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 …
Generic Drugs Forum (GDF) 2025 - 04/09/2025 | FDA
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.
FDA Roundup: March 4, 2025
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 …
Generic Drugs Undergo Rigorous FDA Review | FDA
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.
The Center for Research on Complex Generics | FDA
Jun 2, 2024 · FDA awards a 5-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG).
Office of Generic Drugs 2023 Annual Report | FDA
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 …