The company Leo Pharma B.V. has informed the Medicines Evaluation Board (MEB) that the production of the antibiotic Fucidin (sodium fusidate) is to be halted for the Dutch market for business-economic reasons. This concerns the 250 mg film-coated tablet (RVG 01369).
Arrevus, a clinical stage biopharmaceutical company committed to the development of innovative therapies to treat orphan or serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ARV-1801 for the treatment of cystic fibrosis (CF). Orphan Drug Designation provides for close guidance by the FDA, potentially accelerating time to marketing approval and also includes the potential for orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
RALEIGH, N.C.--(BUSINESS WIRE)--Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.