FDA Approves Serono's Gonal-f Pen Injectable Device To Treat Infertility
June 1, 2004
Serono USA, the U.S. unit of Geneva-based biotechnology company Serono, on Thursday announced it has received FDA approval for its Gonal-f pen, a ready-to-use device that delivers an injectable infertility hormone treatment, the AP/Springfield News Sun reports (AP/Springfield News Sun, 5/27). Gonal-f pen is a prefilled device that administers a new liquid formulation of the gonadotropin follicle stimulating hormone. The device is unique in the United States, according to Serono. The Gonal-f pen will be available in three doses: 300 IU, 450 IU or 900 IU. Patients can choose the correct dose by "dialing" the device without mixing medications or loading cartridges filled with the hormone, according to a Serono release (Serono release, 5/27). FSH is used to induce ovulation in women for whom the cause of infertility is "functional and not due to primary ovarian failure," according to the AP/News Sun (AP/Springfield News Sun, 5/27). The device also is approved to treat infertility in men, Reuters reports. Serono received approval for the device from the European Commission in February and expects to begin selling it in Europe soon, according to Reuters (Reuters, 5/27).
If you like this article, we'd be honored if you shared it using the button below.