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Basilea Pharmaceutica AG Announces Isavuconazole Orphan Drug Designation For Treatment Of zygomycosis By U.S.


Monday, 18 Nov 2013 01:16am EST 

Basilea Pharmaceutica AG announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of zygomycosis (also known as mucormycosis), a life-threatening fungal infection. Basilea announced on May 28, 2013 that the FDA granted isavuconazole orphan drug designation for the treatment of invasive aspergillosis. An FDA orphan drug designation provides several benefits to the sponsor including a seven-year market exclusivity in the United States dating from product approval. Isavuconazole also has FDA fast track status, which has the goal of getting important new drugs to patients with life-threatening conditions as quickly as possible.