EMD Serono Gets Injector Pen Approved

EMD Serono, Inc., a subsidiary of Merck KGaA, has received FDA approval for the 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.

Gonal-f RFF Redi-ject 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.

“EMD Serono is excited and proud to bring the Gonal-f RFF Redi-ject 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 U.S. Fertility Franchise at EMD Serono.

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