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  1. 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.

  2. First Generic Drug Approvals | FDA

    Oct 23, 2025 · FDA considers first generics to be important to public health, and prioritizes review of these submissions.

  3. 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.

  4. 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 name drug ...

  5. Generic Drugs Undergo Rigorous FDA Review | FDA

    FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. About 9 in 10 prescriptions filled in the U.S. are for generics.

  6. 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 applications ...

  7. 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.

  8. 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) …

  9. 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 applications ...

  10. Fiscal Year 2025 Generic Drug Science and Research Initiatives Public ...

    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 regulatory …