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EMD Serono obtains FDA approval for new fertility pen

MDBR Staff Writer Published 21 October 2013

EMD Serono, a subsidiary of Merck Serono, has obtained an approval from the US Food and Drug Administration (FDA) for the Gonal-f RFF Redi-ject, designed for patient self-administration of Gonal-f (recombinant follitropin alfa) with demonstrated dose accuracy.

Gonal-f RFF Redi-ject is a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF (revised formulation female).

The fertility pen has been redesigned to incorporate the patient and provider feedback.

Gonal-f is a recombinant human follicle-stimulating hormone that will supplement or replace the naturally occurring follicle-stimulating hormone.

Merck Serono research and development global head Annalisa Jenkins noted with a complete portfolio of gonadotropins, the company is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals.

"We have a strong legacy in fertility, and the approval of the Gonal-f RFF Redi-ject in the U.S. further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future.

"We will continue to pioneer innovative science that advances our goal of improving pregnancy outcomes and take home baby rates," Jenkins added.

The Gonal-f fertility pens have been introduced in 64 countries globally.

The Gonal-f RFF Redi-ject will be available in three sizes of 300 IU, 450 IU and 900 IU in the US in December 2013.