
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 Drugs | FDA
Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.
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.
First Generic Drug Approvals | FDA
Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.
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 …
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 …
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.
Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly …
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 …
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 …