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FDA Publishes Guidance for Industry: Evaluation of Therapeutic Equivalence
Today, the U.S. Food and Drug Administration published guidance for industry, Evaluation of Therapeutic Equivalence, which revises and finalizes the draft version published in July 2022. This final guidance clarifies the processes by which certain applicants may request therapeutic equivalence (TE) codes and explains FDA’s TE evaluations, including the assignment of TE codes. Therapeutic equivalents are approved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated and which are equally safe and effective for patients when used under the conditions specified in the labeling.
TE evaluations are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the ”Orange Book”), which can assist in determining when drug products may be substituted for one another. TE evaluations serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education about drug product selection. If lower-cost, therapeutically equivalent drug products are available, American consumers have more treatment options with the same safety, efficacy, and quality.
The agency is publishing this guidance as part of the Drug Competition Action Plan, which aims to facilitate more generic competition, promote patient access, and ultimately improve health care costs.
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