Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Monday that it has secured marketing authorisation in Finland for Melatonin Newbury 2 mg prolonged-release tablets, marking the first approval in a Nordic registration procedure.
National reviews in Sweden, Norway, and Denmark are expected to conclude with approvals shortly.
The product is a generic version of Circadin and is indicated as monotherapy for the short-term treatment of primary insomnia in patients aged 55 and over with poor sleep quality. The Nordic market for this treatment is valued at approximately EUR11m annually, according to DLMI Nordic Pharma Insights.
This marks Newbury's second marketing authorisation in Finland and reflects the company's strategy to expand its product portfolio across the region. CEO Lars Minor said the approval underscores Newbury's capability to offer a diverse range of pharmaceutical products.
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