- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-5767.