Newbury Pharmaceuticals is pleased to announce the successful Marketing Authorization (MA) of Melatonin Newbury 2 mg prolonged-release tablets in Finland as the first country in a Nordic registration procedure. Approvals in Sweden, Norway and Denmark are expected to follow upon finalized national reviews.
Melatonin Newbury is indicated as monotherapy for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over. Melatonin Newbury is a generic version of Circadin. The current annual value of the Nordic market is estimated to be 11 MEUR according to DLMI Nordic Pharma Insights.
“The successful approval of Melatonin Newbury highlights Newbury's capability to offer a diverse and comprehensive portfolio and it is also Newbury’s second marketing authorization in Finland” says Mr Lars Minor CEO of Newbury