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# Pfenex NDA for Forteo ‘Me-too’ Copy
- URL: https://www.fdaweb.com/pfenex-nda-for-forteo-me-too-copy/
- Published: 2018-12-10T12:00:00.000Z
- Updated: 2026-09-15T00:49:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143000

Pfenex has submitted an NDA for PF708, indicated for treating osteoporosis. The 505(b)(2) NDA submission, which references Eli Lilly’s Forteo (teriparatide), is based on positive data from the PF708-301 Phase 3 clinical study that showed comparable overall profiles between PF708 and Forteo after 24 weeks of daily injection in osteoporosis patients. It also includes data from the PF708-101 study, a single-dose, two-way crossover study comparing the pharmacokinetics of PF708 and Forteo in healthy subjects.