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# Amneal Asks Forteo Generic Restrictions
- URL: https://www.fdaweb.com/amneal-asks-forteo-generic-restrictions/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139974

Amneal Pharmaceuticals is asking FDA 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.