Approval by the Korean regulatory agency was based on the Australian approval and was completed efficiently in just six months. The approval process is expected to conclude in the third quarter of 2008.
Pharmaxis will now commence pre-marketing with its Korean distributor BL&H, while seeking reimbursement approval through the national health scheme.
Alan Robertson, CEO of Pharmaxis, said: “This is the first Asian approval of Aridol. The existing broad acceptance of lung function challenge tests presents a firm opportunity for marketing Aridol.”