EMD Serono, a subsidiary of Merck KGaA, has announced that Gonal-f RFF Redi-ject, a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF, is now available in the US for distribution.
Gonal-f RFF Redi-ject was approved by the US Food and Drug Administration (FDA) on 17 October 2013.
EMD Serono US Fertility and Endocrinology head and senior vice president Craig Millian noted the company is excited that Gonal-f RFF Redi-ject (follitropin alfa injection) is now available to patients and customers.
"This device was designed with feedback from Healthcare Professionals (HCPs), patients and significant others. 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," Millian added.
The Gonal-f RFF Redi-ject is available in three pen sizes: 300 IU, 450 IU and 900 IU.
Gonal-f RFF Redi-ject has been available in wholesaler channels since 9 December 2013. It is anticipated that pharmacies will be fully stocked by 16 December.
To facilitate refills and supplementary orders for patients who have been trained on the Gonal-f RFF Pen (not Redi-ject), EMD Serono will maintain a small inventory of the Gonal-f RFF Pen for a limited time.