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# Petition Denied on Forteo ANDA Restrictions
- URL: https://www.fdaweb.com/petition-denied-on-forteo-anda-restrictions/
- Published: 2018-01-08T12:00:00.000Z
- Updated: 2026-09-14T23:11:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140438

FDA has denied a 10/2017 Amneal Pharmaceuticals petition asking it not to approve any ANDAs for generic forms of its Forteo (teriparatide \[rDNA origin\]) injection that contain synthetically derived teriparatide active substance, and to only approve ANDAs for teriparatide injection products that contain recombinant human parathyroid hormone. The petition says that an ANDA based on a synthetically derived substance could not satisfy the Forteo labeling requirements that are based on a recombinant human parathyroid hormone.

  
In its denial action, (XXINSERT LINKXX) FDA says it has issued a draft guidance on recommendations for submitting ANDAs for certain highly purified synthetic peptide drug products. It notes that the agency is continuing to consider the circumstances for such ANDAs to be filed and urges Amneal to participate in the guidance’s development by submitting comments. It also declined to address issues in the petition “because to do so would be premature.”