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ANDAs for Certain Highly Purified Synthetic Peptide Drug Products

Updated: Aug 21, 2021

The 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 ANDA under section 505(j) of the 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.

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