US FDA seeks more information on Maxigesic IV® application

AFT Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its application for the US registration of Maxigesic IV®, an intravenous form of its patented pain relief medicine.

The FDA have requested additional data on one remaining issue.

AFT is discussing the FDA’s request with their development and commercialisation partner Hyloris Pharmaceuticals, and will update the market on revisions to the commercialisation pathway and timeline for the medicine.