The U.S. Food and Drug Administration (FDA) today announced approval of Follistim®-AQ TM cartridge (follitropin beta injection) in the United States. Follistim-AQ cartridge is the first follicle stimulating hormone (FSH) treatment available in a pre-filled, pre-mixed solution, eliminating the need for patients to mix one or more vials of medication.
Follistim-AQ cartridge is designed to be used only with the Follistim® PenTM, an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection, a highly effective and widely used prescription fertility medication.
Follistim is prescribed for women undergoing assisted reproductive treatments (ART) such as in vitro fertilization (IVF), and for the induction of ovulation to achieve pregnancy. Follistim-AQ cartridge, used with the Follistim Pen, provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. Organon USA Inc. markets Follistim-AQ cartridge and Follistim Pen. In Europe it is marketed under the brand name Puregon® PenTM.