ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

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.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Language(s):
English
Format:
Text
Subject(s):
Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
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 assist potential applicants in determining when an application for a synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) under section 505(b) of the FD&C Act. Specifically, this guidance provides recommendations for evaluating whether an ANDA submission is appropriate for a synthetic peptide that references any of the following five previously approved peptide drug products of rDNA origin: glucagon, liraglutide, nesiritide, teriparatide, and teduglutide.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (12 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918350982606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918350982606676