FDA Approves New Version of Gonal-f Prefilled Pen

GONAL-f (follitropin alfa injection) is a recombinant human follicle-stimulating hormone (r-hFSH) approved for the treatment female infertility and a rare form of male infertility.

Merck announced that the Food and Drug Administration (FDA) has approved Gonal-f RFF Redi-ject prefilled pen, a new version of Gonal-f (follitropin alfa injection) prefilled pen. 

Gonal-f was initially approved in 2013 for the treatment of of female infertility and for the induction of spermatogenesis in men with hypogonadotropic hypogonadism without testicular failure. The recombinant human follicle-stimulating hormone (r-FSH) supplements or replaces naturally occurring FSH, which is essential to treat infertility. It stimulates ovarian follicular growth in women without primary ovarian failure.  

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Like the previous version, the Gonal-f pen features dose titration in 12.5 IU increments, allowing for a range of doses to fit patient needs. The new design also includes an update to the display window for improved readability. 

The ready-to-use pens will be available as Gonal-f 300 IU, 450 IU, and 900 IU strengths. Each Redi-ject is supplied in a carton containing disposable needles and the prefilled multiple-dose delivery system.

For more information call (800) 283-8088 or visit emdserono.com.