Newbury Pharmaceuticals
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Newbury Pharmaceuticals Secures Generic Approval for Palbociclib Newbury
Newbury Pharmaceuticals is pleased to announce the successful Marketing Authorization (MA) of Palbociclib Newbury tablets in Denmark as the first country in a Scandinavian registration procedure. Approvals in Sweden and Norway are expected to follow upon finalized national reviews.
Palbociclib Newbury, a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6, is a medication for the treatment of HR-positive and HER2-negative breast cancer. Palbociclib Newbury is a generic version of Ibrance. The current annual value of the Scandinavian market is estimated to be 21 MEUR according to DLMI Nordic Pharma Insights.
“The successful approval of Palbociclib Newbury highlights Newbury's capability to offer a comprehensive portfolio within oncology. Based on this positive progress, we will proceed to launch this product within respective markets as soon as regulatory exclusivities and patents allow us.” says Mr Karl Karlsson CEO of Newbury
| Datum | 2026-04-17, kl 10:00 |
| Källa | MFN |