Posted by Michael Wonder on 03 Dec 2018
Zambon announces approval and ARTG listing of safinamide in Australia for treatment of patients with Parkinson’s disease
30 November 2018 - Further regulatory submissions on-going with authorities worldwide.
Zambon and its partner Newron Pharmaceuticals today announced the recent approval of Xadago (safinamide) in Australia by the TGA of the Australian Government Department of Health for the treatment of adult patients with fluctuating idiopathic Parkinson’s disease as add-on therapy to a regimen that includes levodopa.
Xadago has been registered on the Australian Register of Therapeutic Goods, which is the formal requirement for supply and marketing of the medicine. Under a partnership agreement with Zambon, Seqirus, a global leader in influenza prevention and a leading provider of essential vaccines and pharmaceuticals in Australia and New Zealand, has undertaken the registration with the Australian authorities and will now work to supply Xadago.
