Announcement
GENERAL: AFT: US FDA seeks more information on Maxigesic IV(R) application
02:39pm
AFT
01/07/2022 14:39
GENERAL
PRICE SENSITIVE
REL: 1439 HRS AFT Pharmaceuticals Limited
GENERAL: AFT: US FDA seeks more information on Maxigesic IV(R) application
1 July 2022
US FDA seeks more information on Maxigesic IV(R) 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(R), 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(R) 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 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
End CA:00394742 For:AFT Type:GENERAL Time:2022-07-01 14:39:55
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