The maker of the Maxigesic pain relief medication has launched its intravenous product in the United States.
AFT Pharmaceuticals said the product, known as Maxigesic IV, was released in the US by its licensee Hikma Pharmaceuticals, under the brand Combogesic IV.
The drug was approved by the US Food and Drug Administration (FDA) in October 2023.
It said it was the first patented, New Zealand-developed medicine with clinical studies in the US healthcare market.
AFT said the first commercial sale in the US would likely happen in the coming weeks, triggering a US$6 million licensee fee to AFT and its development partner, Hyloris, in Belgium.
It said AFT's share of the license fee would accrue in the current financial year, estimated to be about NZ$6m.
"The launch of Maxigesic IV in the US, the world's largest market for pain relief, is a significant achievement for AFT," said co-founder and managing director Hartley Atkinson.
"We are delighted with the speed with which our partner Hikma, a leading supplier of injectable medicines in the US and around the world, has brought the medicine to market post-approval and the opportunity it shares with us on the potential of the medicine."
Atkinson said its next goal was finalising plans to launch the prescription-only tablet, Maxigesic Rapid.