Sep 16, 2025 · Detailed information on FDA's rigorous review process for generic drugs Generic Competition and Drug Prices Information on how the introduction of generics leads to lower prices for …

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 ...

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 ...

Mar 13, 2025 · Understanding generic drugs. Consumer-friendly information on the safe and effective use of generic drugs.

Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines.

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

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 ...

Generics (typically small molecules) and biosimilars (typically larger, more complex molecules) are approved through different abbreviated pathways that avoid duplicating certain costly clinical ...

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 ...

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