US FDA sets PDUFA date for Maxigesic IV®

AFT Pharmaceuticals today announces the US Food and Drug Administration has set 17 October 2023 as the date by which it expects to respond to AFT’s application to register Maxigesic IV in the US.

The FDA provided the Prescription Drug User Fee Act (PDUFA) date in a letter confirming it had received a complete response in relation to its questions on extractables and leachables from Maxigesic IV’s primary packaging (the glass vial in which the medicine is stored and the vial’s stopper). The FDA requested the additional data in July 2022.

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 around 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.

Released for and on behalf of AFT Pharmaceuticals by Malcolm Tubby, Chief Financial Officer.

For more information:

Richard Inder
The Project
Tel: +64 9488 0232

Dr Hartley Atkinson
Managing Director
AFT Pharmaceuticals Tel: +64 21 645 643