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  1. fda.gov
    https://www.fda.gov › drugs › frequently-asked-questions-popular-topic…

    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. fda.gov
    https://www.fda.gov › drugs › generic-drugs › generic-drug-facts

    Generic Drug Facts | FDA

    1 Samh 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.

  3. fda.gov
    https://www.fda.gov › news-events › press-announcements

    FDA Roundup: March 4, 2025

    4 Márta 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 …

  4. fda.gov
    https://www.fda.gov › drugs › generic-drugs

    Office of Generic Drugs 2023 Annual Report | FDA

    4 Márta 2024 · Our 2023 Annual Report provides highlights of activities and accomplishments including generic drug approvals, first generic approvals, science and research innovations for …

  5. fda.gov
    https://www.fda.gov › drugs › drug-safety-and-availability › fda-announc…

    FDA Announces New ANDA Prioritization Pilot

    3 DFómh 2025 · FDA is announcing a new pilot prioritization program for the review of abbreviated new drug applications (ANDAs).

  6. fda.gov
    https://www.fda.gov › drugs › news-events-human-drugs

    Generic Drugs Forum (GDF) 2025 - 04/09/2025 | FDA

    20 Noll 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.

  7. fda.gov
    https://www.fda.gov › drugs › guidances-drugs › product-specific-guida…

    Product-Specific Guidances for Generic Drug Development | FDA

    26 Márta 2025 · To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing …

  8. fda.gov
    https://www.fda.gov › drugs › abbreviated-new-drug-application-anda › …

    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 …

  9. fda.gov
    https://www.fda.gov › drugs › generic-drugs › complex-generics-news

    Complex Generics News | FDA

    22 Samh 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.

  10. fda.gov
    https://www.fda.gov › drugs › drug-approvals-and-databases › approve…

    Approved Drug Products with Therapeutic Equivalence …

    10 DFómh 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.