Pirfenidone Newbury approved by the Norwegian Health Authorities
Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Pirfenidone Newbury 267 & 801 mg film-coated tablets in Norway as the first country in a Scandinavian registration procedure. Approvals in Sweden and Denmark are expected to follow upon finalized national reviews.
“This high asset rare disease medicine further strengthens the ambition to have a positive impact in society with products and technologies that contribute to the overall health care system and patient well-being. Based on this positive progress, we will proceed to launch this product, within our respective markets as soon as regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.
Pirfenidone is a medicine used to treat adults with mild to moderate idiopathic pulmonary fibrosis (IPF). IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath. Our product has been developed based on the reference brand Esbriet.
