EMD Serono Receives FDA Approval for Redesigned Fertility Pen


EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) approved Gonal-f RFF* Redi-ject (follitropin alfa injection), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF.

"EMD Serono is excited and proud to bring the Gonal-f RFF Redi-ject (follitropin alfa injection) to the market. This device was designed with key features based on feedback we received from Healthcare Professionals (HCPs), patients, and significant others," said Craig Millian, Senior Vice President, Head of the US Fertility Franchise at EMD Serono. "Bringing the Gonal-f RFF Redi-ject to market aligns directly to our mission, which is to create, innovate, and advocate for people who want to have a child. EMD Serono has a long heritage of fertility expertise, and we will continue to invest in emerging science, patient-centric programs, and our existing product portfolio to achieve our goal of reducing barriers to treatment."

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

For more information about the Gonal-f RFF Redi-ject, please call Fertility Lifelines at 1-866- 538-7879.

For information about Gonal-f RFF Redi-ject, please click here to visit emdserono.com for the Prescribing Information. Patients should consult their health care provider for additional information.

Gonal-f RFF Redi-ject™(follitropin alfa injection) is indicated for: Induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure, development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Prior to initiation of treatment with Gonal-f RFF Redi-ject: Women should have a complete gynecologic and endocrinologic evaluation and diagnose the cause of infertility. Primary ovarian failure and potential pregnancy should be excluded. Tubal patency should be demonstrated.

Source: EMD Serono, Inc.