FDA approves Menopur/Bravelle combination as Fertility treatment - Ferring Pharma
Ferring Pharmaceuticals has announced FDA approval of new labeling for their Fertility products, Menopur (menotropins for injection) and Bravelle (urofollitrophin). The label update is a result of the COMBINE trial which demonstrated that both drugs 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.
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.
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