Redesigned Fertility Pen Receives FDA Approval

Gonal-f RFF Redi-ject (recombinant follitropin alfa), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF (revised formulation female), has been approved by the FDA. Marketed as Gonal-f RFF Redi-ject by Merck Serono subsidiary EMD Serono Inc, this redesigned system is based on feedback from both patients and health care providers.

According to EMD Serono, Gonal-f RFF Redi-ject is part of a global family of prefilled pens designed for patient self-administration of Gonal-f, an injectable recombinant follitropin alfa. These prefilled pens have demonstrated dose accuracy and are designed with physicians and patients in mind. Gonal-f is prescribed to supplement or replace naturally occurring follicle-stimulating hormone, an essential hormone to treat infertility, which affects approximately 1 in 8 couples in the United States.

This redesigned system will be available in December 2013 in three pen sizes: 300 IU, 450 IU, and 900 IU. According to prescribing information, 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 caused by primary ovarian failure and development of multiple follicles in ovulatory women as part of an assisted reproductive technology cycle.

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Reference

EMD Serono receives FDA approval for redesigned fertility pen [news release]. Available

here

. Accessed October 22, 2013.