PARSIPPANY, N.J., - Ferring Pharmaceuticals Inc. today announced FDA approval of new labeling for their 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 U.S. 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.