US FDA sets PDUFA date for Maxigesic IV

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN: ARBN 609 017 969 investor.relations@aftpharm.com





1 May 2023
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.
For and on behalf of AFT Pharmaceuticals Limited by Malcolm Tubby, Chief Financial
Officer.
For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9 488 0232

About AFT Pharmaceuticals
AFT is a growing multinational pharmaceutical company that develops, markets, and
distributes a broad portfolio of pharmaceutical products across a wide range of
therapeutic categories which are distributed across all major pharmaceutical
distribution channels: over the counter (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded, and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and in certain Southeast Asian markets, and to out-license our products to
local licensees and distributors to the rest of the world. For more information:
www.aftpharm.com