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Referencing approved drug products in ANDA submissions
Referencing approved drug products in ANDA submissions
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval
Drugs, Generic
Reference Books, Medical
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- This guidance is intended to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an abbreviated new drug application (ANDA) submission. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the Food and Drug Administration (FDA or the Agency) an ANDA to seek approval to market a generic drug. FDA’s regulations use certain terms for products that relate to an ANDA. In general, to obtain approval of an ANDA for a generic drug, an ANDA applicant first must identify the previously approved drug product it seeks to duplicate, i.e., the reference listed drug (RLD), and must show, among other things, that the generic drug is bioequivalent to the RLD. A reference standard, which is selected by FDA, is the specific drug product that the ANDA applicant must use in conducting any in vivo bioequivalence testing required to support approval of its ANDA. The reference standard selected by FDA is ordinarily the RLD. However, there may be circumstances (e.g., when the RLD is no longer marketed) in which the reference standard is a drug product other than the RLD. In addition, FDA regulations require an ANDA applicant to include in an ANDA its “basis for ANDA submission” (referred to hereinafter as basis of submission). The basis of submission includes, among other things, the name of the RLD.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (16 pages)).
- NLM Unique ID:
- 9918248909906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918248909906676