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          ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry
					Guidance for Industry
		
		May 2021


	Download the  Final Guidance Document
	    
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    Final
		
		    		Level 1 Guidance

	  
	  
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    PrintDocket Number:
		    FDA-2017-D-5767
	    	    		    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 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. .


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-5767.

                                                                                  Content current as of:
      05/19/2021
         
                  
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