FDA Drops New Guidance on Generic Drug Equivalence Ratings
Published Date: 8/24/2026
Notice
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Evaluation of Therapeutic Equivalence." This guidance explains FDA's thinking on therapeutic equivalence evaluations and therapeutic equivalence codes (TE codes). FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the "Approved Drug Products With Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). These therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. This guidance finalizes the draft guidance of the same title issued in July 2022.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Orange Book TE Evaluations Aid Cost Containment
The FDA finalized guidance explaining therapeutic equivalence evaluations and therapeutic equivalence (TE) codes that are listed in the Active section of the Orange Book for multisource prescription drug products approved under the FD&C Act. The guidance says these TE evaluations are public information for state health agencies, prescribers, and pharmacists to promote public education and to "foster containment of health care costs." The guidance availability is announced August 24, 2026.
New Process for 505(b)(2) Applicants to Request TE Codes
The final guidance includes revisions that reflect an additional process by which applicants of certain 505(b)(2) applications may request therapeutic equivalence (TE) codes. This change is part of the finalized guidance announced August 24, 2026, and relates specifically to applicants of 505(b)(2) drug applications.
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