Trial Profile
A bioequivalence study in healthy subjects for PF-708
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 06 Dec 2023
Price :
$35
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At a glance
- Drugs Teriparatide (Primary)
- Indications Osteoporosis
- Focus Pharmacokinetics; Registrational
- 07 Oct 2019 According to a Pfenex media release, the company is conducting a comparative human factors study between PF708 and Forteo as requested by FDA. Pfenex anticipates submitting the final study report to the FDA as early as the second half of October 2019 and believes that this completes the information package required by the FDA to evaluate the therapeutic equivalence of PF708.
- 07 Oct 2019 According to a Pfenex media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved the new drug application for PF708 submitted under the 505(b)(2) regulatory pathway, with Forteo (teriparatide injection) as the reference drug.
- 08 Aug 2019 According to a Pfenex media release, the FDA has completed its mid-cycle review of NDA for PF708 in May and did not identify any issues that require an advisory committee meeting. In anticipation of the FDA's decision on NDA for PF708, the company is planning on the launch readiness with commercial partner Alvogen.