ROCKLAND, Mass. — A redesigned version of an injector pen used to treat infertility is available for distribution in the United States, the manufacturer said Monday.
EMD Serono, a subsidiary of German drug maker Merck KGaA, said that Gonal-f RFF Redi-ject, a disposable, pre-filled pen used for the drug Gonal-f RFF (follitropin alfa), had become available. The Food and Drug Administration approved the redesigned pen in October. Merck KGaA operates in the United States under the name EMD in order to avoid confusion with U.S.-based Merck & Co.
"This device was designed with feedback from healthcare professionals, patients and significant others," EMD Serono SVP and head of U.S. fertility and endocrinology Craig Millian said. "EMD Serono has a long heritage of fertility expertise and is committed to strengthening that legacy. Adding this device to our product portfolio helps to further our mission, which is to create, innovate and advocate for people who want to have a child, with the goal of reducing barriers to treatment."