Home » EMD Serono Wins FDA Nod for Redesigned Pen Injector
EMD Serono Wins FDA Nod for Redesigned Pen Injector
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.
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