Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Thursday that it has been granted Marketing Authorization for Ivermectin Newbury 10 mg/g cream in Denmark, marking the first approval in its Scandinavian registration process.
Approvals in Norway and Sweden are expected following completion of national reviews.
The cream treats facial redness caused by rosacea and is a generic version of Soolantra. The Scandinavian market for ivermectin cream is currently valued at approximately EUR2.8m, according to DLMI Nordic Pharma Insights.
CEO Lars Minor said that this marks Newbury's first product in dermatology and demonstrates its ability to expand its product portfolio. The company plans to launch Ivermectin Newbury in relevant markets once regulatory exclusivities and patents permit.
Amneal's risperidone extended-release injectable suspension approved by US FDA
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Viatris' generic iron sucrose injection gains US FDA approval
Newbury Pharmaceuticals gains Finnish approval for generic melatonin
CivicaScript to distribute biosimilar for chronic inflammatory conditions
Mallinckrodt and Endo complete merger
Zenara Pharma's Sertraline Hydrochloride Capsules generic receives US FDA approval
EQT agrees to acquire majority stake in Adalvo
Mallinckrodt receives Irish High Court ruling to combine with Endo Inc
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CivicaScript introduces low-cost multiple sclerosis treatment
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Glenmark Therapeutics launches Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
AB Science secures Canadian patent for AB8939, completing global IP coverage for AML treatment