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# Guidance on ANDAs for Some Peptides
- URL: https://www.fdaweb.com/guidance-on-andas-for-some-peptides/
- Published: 2021-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:59:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149353

FDA has published a guidance, *ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin*, to assist potential applicants in determining when an application for a synthetic peptide that refers to a previously approved peptide drug product of rDNA origin should be submitted as an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act rather than as an NDA under section 505(b). Specifically, FDA says, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-certain-highly-purified-synthetic-peptide-drug-products-refer-listed-drugs-rdna-origin?ref=fdaweb.com) provides recommendations for evaluating whether an ANDA submission is appropriate for a synthetic peptide that references any of the five previously approved peptide drug products of rDNA origin: glucagon, liraglutide, nesiritide, teriparatide, and teduglutide.

FDA says that given the current state of technology for peptide synthesis and characterization, it is now possible for an ANDA applicant to demonstrate that the active ingredient in a proposed generic synthetic peptide is the “same” as the active ingredient in a previously approved peptide of rDNA origin.