Newbury Pharmaceuticals Secures Generic Approval for Dalbavancin Newbury
Newbury Pharmaceuticals is pleased to announce the successful Marketing Authorization (MA) of Dalbavancin Newbury 500 mg powder for concentrate for solution for infusion in Sweden. No further country approvals are planned at this time.
Dalbavancin Newbury, a long-acting lipoglycopeptide antibiotic, is a medication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, administered by intravenous infusion in a hospital setting. Dalbavancin Newbury is a generic version of Xydalba. The current annual value of the Swedish market is estimated to be 4 MEUR according to DLMI Nordic Pharma Insights. This approval marks Newbury's entry into the hospital injectable segment, reflecting the company's ambition to broaden its product offering beyond oral formulations.
“Dalbavancin Newbury is an important milestone for us, as it is our first own injectable product for the hospital segment. This approval demonstrates our ability to expand beyond oral formulations and into hospital-administered treatments, and we look forward to launching this product in the near future.” says Mr Karl Karlsson CEO of Newbury
For more information, contact:
Karl Karlsson, CEO
karl.karlsson@newburypharma.com
Mobile: +46 46 12 11 20
About Newbury Pharmaceuticals
Newbury Pharmaceuticals is building a pipeline of proprietary and licensed products with focus on specialty and branded products in the Nordics. Newbury aims to make a difference by offering treatment solutions within areas like oncology, rare diseases and neurology. The portfolio is built by leveraging experience and an extensive international network. Newbury offers strategic partnerships of innovation for the benefit of the Nordic healthcare market.
Västra Hamnen Corporate Finance is the Company's Certified Adviser on Nasdaq First North and can be reached at ca@vhcorp.se or +46 (0) 40 200 250.