Newbury Pharmaceuticals Secures Generic Approval for Prukalopride Newbury
Newbury Pharmaceuticals Secures Generic Approval for Prukalopride Newbury
Newbury Pharmaceuticals is pleased to announce the successful Marketing Authorization (MA) of Prukalopride Newbury 1 mg and 2 mg film-coated tablets in Sweden. No further country approvals are planned at this time.
Prukalopride Newbury, a selective, high affinity 5-HT4 receptor agonist, is a medication for the symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief. Prukalopride Newbury is a generic version of Resolor. The current annual value of the Swedish market is estimated to be 0,58 MEUR according to DLMI Nordic Pharma Insights. The approval is the result of the strategic partnership announced in March 2026 and further strengthens Newbury’s growing portfolio of specialty products in the Nordics.
“The approval of Prukalopride Newbury shows that our partnership strategy delivers. Only months after signing the agreement, we now have a marketing authorization in place, offering Swedish patients and healthcare an additional treatment option for chronic constipation. Newbury is a company with high ambitions, and we look forward to launching this product in the near future.” says Mr Karl Karlsson CEO of Newbury.