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GUIDANCE DOCUMENT

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry October 2017

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist potential applicants in determining when an application for a 14 synthetic peptide drug product (synthetic peptide) that refers to a previously approved peptide 15 drug product of recombinant deoxyribonucleic acid (rDNA) origin (peptide of rDNA origin) 16 should be submitted as an abbreviated new drug application (ANDA) under section 505(j) of the 17 Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new drug application (NDA) 18 under section 505(b) of the FD&C Act. Specifically, this guidance covers the following five 19 peptide drug products: glucagon, liraglutide, nesiritide, teriparatide, and teduglutide.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.