EMD Serono wins FDA nod for redesigned pen injector

Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving 86 women with infertility and 30 fertility nurses. Get the full story at our sister site, Drug Delivery Business News. The post EMD Serono wins FDA nod for redesigned pen injector appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Wall Street Beat Women's Health emdserono Merck KGaA Source Type: news