Description
The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate. The guidance explains how FDA evaluates drug products for, and determines TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). The guidance provides background on the fundamentals of TE and utilizes a question and answer format to provide more information on the therapeutic equivalence evaluation of approved drug products and assignment of TE codes in the Orange Book.
Scope & Applicability
Product Classes
5Products evaluated for therapeutic equivalence
Products comprised of two or more regulated components
Reference Listed Drug used as the basis for an ANDA submission.
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Combination product with a user interface
Stakeholders
3Entity responsible for submitting NDINs
Entity responsible for maintaining generic drug labeling
Role involved in changing amendment classification; The regulatory project manager will issue the applicant an acknowledgment letter
Regulatory Context
Attributes
7Requirement for therapeutic equivalence
Therapeutic equivalence rating in the Orange Book
Requirement for therapeutic equivalence
Assigned when bioequivalence problems are resolved with evidence
Assigned when bioequivalence problems have not been resolved
coding system (e.g., AB, BX) used in the Orange Book
drug products that contain the same active ingredient(s), dosage form, route of administration, and strength
Related CFR Sections (7)
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
- 21CFR314.127§ 314.127 Refusal to approve an ANDA.
(a) FDA will refuse to approve an ANDA for a new drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act for any of the following reasons, unless the requirement has been waived under § 314.99 :Read full regulation →
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR10.25§ 10.25 Initiation of administrative proceedings.
An administrative proceeding may be initiated in the following three ways:Read full regulation →
- 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
(a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →
- 21CFR314.161§ 314.161 Determination of reasons for voluntary withdrawal of a listed drug.
(a) A determination whether a listed drug that has been voluntarily withdrawn from sale was withdrawn for safety or effectiveness reasons may be made by the agency at any time after the drug has been voluntarily withdrawn from sale, but must be made:Read full regulation →
See Also (8)
- Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (Status: Draft)
- Formas posológicas orales sólidas de liberación inmediata Cambios de escala y posteriores a la aprobación: documentación química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo. (Status: Final)
- SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (Status: Final)
- SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (Status: Final)
- SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation: Guidance for Industry (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)