Newbury Pharmaceuticals Secures Generic Approval for Dalbavancin Newbury
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