
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.
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 disease (CAD) …
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 generic …
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.
FDA Announces New ANDA Prioritization Pilot
Oct 3, 2025 · FDA is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs).
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.
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.
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 drugs and …
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 ...