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.
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.
Product-Specific Guidances for Generic Drug Development | FDA
Mar 26, 2025 · To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing …
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 …
First Generic Drug Approvals | FDA
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.
Office of Generic Drugs 2022 Annual Report | FDA
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 ...
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).
Complex Generics News | FDA
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.
Generic Competition and Drug Prices | FDA
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 …
Approved Drug Products with Therapeutic Equivalence Evaluations ...
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.