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# Pfenex NDA Approved for Forteo Copy
- URL: https://www.fdaweb.com/pfenex-nda-approved-for-forteo-copy/
- Published: 2019-10-07T12:00:00.000Z
- Updated: 2026-09-15T01:54:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145180

FDA has approved a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lilly’s Forteo, indicated for treating osteoporosis in certain patients at high risk for fracture. According to Pfenex, Forteo had $1.6 billion in global sales last year.  
  
Pfenex says it has asked FDA to designate PF708 as therapeutically equivalent (A-rated) to Forteo, which would permit it to be automatically substituted for Forteo in many states. To support this, Pfenex is conducting a comparative human factors study between PF708 and Forteo as requested by the agency. Pfenex expects to submit a final study report later this month and believes that this completes the information package to evaluate the drug’s therapeutic equivalence.