Eurand's UC drug gets orphan status in USA

Eurand NV, a Dutch specialty drug company, says that the US Food and Drug Administration has granted orphan drug designation for EUR-1073  (beclomethasone diproprionate) in pediatric ulcerative colitis  patients. Orphan drug status is granted by the FDA to promote the  development of drugs for diseases that affect fewer than 200,000  patients. Products granted orphan drug status are allowed seven years  of market exclusivity in the USA following FDA approval. The firm noted  that EUR-1073 is part of its strategy to develop a pipeline of  gastroenterology products to be marketed by its own sales force.  EUR-1073 will be complementary to EUR-1008, which is currently under  review by the FDA as a treatment for exocrine pancreatic insufficiency,  the firm added.