This article is more than 5 years old. Information may no longer be current.
FDA approves redesigned follitropin alfa injection pen for fertility treatment
Click Here to Manage Email Alerts
The FDA recently approved a redesigned version of EMD Serono’s follitropin alfa injection pen, which is indicated for induction of ovulation and pregnancy in oligo-anovulatory women, according to a company press release.
The follitropin alfa injection (GONAL-f RFF Redi-ject) pen is for use in women whose cause of infertility is functional and not caused by primary ovarian failure or development of multiple follicles in ovulatory women as part of an assisted reproductive technology cycle.
“As a committed fertility treatment partner, we aspire to develop user-friendly treatment options for patients,” Richard R. Smith, senior vice president and health of U.S. fertility and endocrinology at EMD Serono, said in the release. “The best drivers for innovation come from the insights of people using our products, which is why feedback from patients and health care professionals was critical in redesigning the pen injector features.”
The new design was reported as easy to use in a simulated-use study that included 86 women with infertility and 30 fertility nurses, according to the release.
The pen was first approved by the FDA in October 2013 and is available in three sizes: 300 IU, 450 IU and 900 IU. Follitropin alfa for injection vials (GONAL-f) were originally approved in September 1997.