The US Food and Drug Administration (FDA) has approved new labelling for Ferring Pharmaceuticals, fertility products, Menopur and Bravelle. The label update is a result of the COMBINE trial which demonstrated that both Menopur and Bravelle can be safely mixed and administered in a single injection. Approval was granted on February 19, 2014 and designates Ferring's mixed protocol as the only combination of IVF stimulation gonadotropins to have regulatory backing for being mixed together in a single syringe.
"Ferring is excited to provide an IVF treatment option that requires fewer injections," said Nick Hart, Ferring's Business Unit Head for US Reproductive Health. "We are pleased with the FDA's response and look forward to offering physicians and patients the ability for customization and a simplified treatment protocol."
Support for the safety and stability was provided by a pharmacodynamics study indicating that the mixed protocol does not interfere with the efficient delivery of the indicated dosage of either medication.
Menopur is a prescription medicine that contains hormones. Menopur contains follicle stimulating hormone and luteinizing hormone activity. These hormones stimulate healthy ovaries to make eggs. Menopur is used for women who need medical help to get pregnant.
Bravelle is a prescription medicine that contains hormones. Bravelle contains follicle stimulating hormone which stimulates healthy ovaries to make eggs. Bravelle is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.
Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and in the fields of reproductive health, gynaecology, orthopaedics and gastroenterology.