
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 …
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 …
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 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 List of Authorized Generic Drugs
Jan 13, 2025 · 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 …
Fiscal Year 2025 Generic Drug Science and Research Initiatives …
May 22, 2025 · Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and …
9 Things to Know About Biosimilars and Interchangeable Biosimilars
FDA experts share some interesting facts about to biosimilars and interchangeable biosimilars.
Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly …