US FDA seeks more information on Maxigesic IV(R) application

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969





1 July 2022
US FDA seeks more information on Maxigesic IV® application
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) announces that it has today received a
Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on
its application for the US registration of Maxigesic IV
®
, the intravenous form of its
patented pain relief medicine. The FDA have requested additional data on one
remaining issue.
AFT Managing Director Dr Hartley Atkinson said: “While it is disappointing not to have
received registration of Maxigesic IV as we initially expected, we are confident that
we can deliver the FDA the information that it needs to approve our medicine.
“We are now discussing the FDA’s request with our development and
commercialisation partner Hyloris Pharmaceuticals. We will be updating the market
shortly on revisions to the US commercialisation pathway and timeline for the medicine
as we gain more clarity on the FDA’s request.”
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 currently licensed in more than 100
countries across the globe. It has also been registered in 37 countries and launched
in 7 countries including Australia, 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:
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 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

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969

for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and to out-license / distribute our products to local licensees and distributors
to over 125 countries around the world. For more information about the company, visit
our website: www.aftpharm.com