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.
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 Drugs | FDA
Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.
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 …
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 …
FDA Moves to Accelerate Biosimilar Development and Lower Drug …
Oct 29, 2025 · The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost …
Overview & Basics | FDA
Sep 16, 2025 · The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic …
Fiscal Year 2025 Generic Drug Science and Research Initiatives …
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 …
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 …