FDA confirms earlier than expected PDUFA date for Maxigesic

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





15 Nov 2021
FDA confirms earlier than expected PDUFA date for Maxigesic IV®
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces the US Food and Drug
Administration (FDA) has confirmed an earlier than expected Prescription Drug User
Fee Act (PDUFA) date for Maxigesic IV, the intravenous form of its patented pain relief
medicine.
The PDUFA date – the date at which the FDA must respond to the application - will be
30 June 2022, ahead of the August to September 2022 that AFT had expected.
AFT Managing Director Dr Hartley Atkinson said: “The earlier than envisaged PDUFA
date offers the potential for an earlier registration and launch of Maxigesic IV in the
US with our partner Hikma Pharmaceuticals.

“The launch itself is associated with a significant milestone payment so as long as we
can achieve the PDUFA date this represents a useful time saving on our timeline for
the commercialisation of Maxigesic IV in the US.”

For and on behalf of AFT Pharmaceuticals Limited 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

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

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 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:
aftpharm.com