Merck Serono announced that the FDA has approved EMD Serono‘s GONAL-f RFF Redi-ject (recombinant follitropin alfa) injection, a disposable prefilled drug injector pen indicated for the subcutaneous (SC) injection of a liquid formulation of Gonal-f RFF (Revised Formulation Female).

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GONAL-f RFF is a recombinant human follicle-stimulating hormone (FSH) indicated for development of multiple follicles in ovulatory patients undergoing Assisted Reproductive Technology (ART); for the induction of ovulation in patients with functional anovulatory infertility without primary ovarian failure.

The GONAL-f RFF Redi-ject will be available in 300 IU (0.5mL), 450 IU (0.75mL), and 900 IU (1.5mL) prefilled, multi-dose pen sizes in December 2013.

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