A comparative Human factor study of PF708 and Forteo
Latest Information Update: 06 Dec 2023
At a glance
- Drugs Teriparatide (Primary)
- Indications Osteoporosis
- Focus Therapeutic Use
- 13 Aug 2020 New trial record
- 06 Aug 2020 According to a Pfenex media release, Alvogen has recently provided the FDA with an updated CUHF protocol having taken the totality of feedback into account, including a General Advice Letter dated July 2020 and the company intend to commence the study after the FDA's review of the protocol.
- 06 Aug 2020 According to a Pfenex media release, Following the FDA's April General Advice Letter and as part of an active and on-going dialogue, the FDA has provided additional direction around the methodology to be used in this study focused on a larger group of Forteo experienced users in order to support a therapeutic equivalence evaluation.