AFT Pharmaceuticals Limited (ASX:AFP)
has announced that the investigational new drug application for Maxigesic IV has now been approved by the US FDA.
The pharmaceutical company said this move was the first key step in the regulatory process to seek approval for Maxigesic IV in the US.
AFT Pharmaceutical said the first clinical pharmacokinetic study conducted under the IND in Christchurch, New Zealand has now been opened and patient enrolment will commence in April.
Maxigesic is an analgesic that combines both Paracetamol and Ibuprofen as a painkiller product.