FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

EMD Serono Wins FDA Nod for Redesigned Pen Injector

Nov. 15, 2017
A A

EMD Serono won the FDA’s approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector.

First approved in 2013, the device is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women.

The redesigned pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses.

View today's stories