FDA approves new injector pen for Merck KGaA fertility drug

Agency approves EMD Serono's Gonal-f RFF Redi-ject

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

"With a complete portfolio of gonadotropins, Merck Serono is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals," Merck Serono global head of research and development Annalisa Jenkins said. "We have a strong legacy in fertility, and the approval of the Gonal-F RFF Redi-ject in the [United States] further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future."

Merck Serono, itself part of Merck KGaA, was originally the parent company of Merck & Co., but the two were split during World War I as part of a broader seizure of German assets in the United States. 

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