Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Nintedanib Newbury 100 & 150 mg soft capsules tablets in Sweden as the first country in a Scandinavian registration procedure. Approvals in Norway and Denmark are expected to follow upon finalized national reviews.

“Nintedanib is a terrific supplement to the existing high-value product portfolio and we are proud to further strengthen our commitment within idiopathic pulmonary fibrosis (IPF). 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. Lars Minor, CEO of Newbury.

Idiopathic pulmonary fibrosis (IPF) is a progressive and ultimately fatal lung disease that occurs in older adults.

Nintedanib is a tyrosine kinase inhibitor used to treat adults with:

  • idiopathic pulmonary fibrosis (IPF), a disease of unknown cause in which fibrous tissue forms in the lungs;
  • systemic sclerosis associated interstitial lung disease, a disease in which the immune system (the body’s natural defenses) is overactive, causing production of fibrous tissue and progressive scarring of the lungs;
  • other chronic fibrosing interstitial lung diseases which are progressive.

Our product has been developed based on the reference brand Ofev.

Attachments

Nintedanib Newbury approved by the Swedish Health Authorities

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