AFT Pharmaceuticals (ASX.AFP) has submitted to the US Food and Drug Administration (FDA) data the regulator requested as it considers registration of the company’s patented intravenous pain relief medicine Maxigesic IV.
In a delay to the registration of the medicine in the US, the FDA requested in July 2022 additional data on the performance of Maxigesic IV’s primary packaging (the glass vial in which the medicine is stored and the vial’s stopper).
AFT along with its commercialisation partner Belgium’s Hyloris Pharmaceuticals has over the last year collated the data and submitted today.
We believe the data we have submitted will satisfy the FDA’s requirements and remove the outstanding hurdle to registration. All going well we anticipate registration of the medicine this year and sales to follow shortly after,” Managing Director, Dr Hartley Atkinson, said.
Maxigesic IV, is a novel, unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, for the treatment of post-operative pain. It has been developed in collaboration with Hyloris and is currently licensed in more than 100 countries across the globe. It has also been registered in 43 countries and launched in 19 countries including Australia, France, Germany, and Korea.
The medicine is protected by several granted patents and pending patent applications.