Amphotericin B Inhalation Powder, TRX4

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FDA Approvals

FDA Orphan Drug Approvals: Amphotericin B Inhalation Powder, TRX4,

AT2101

http://www.medscape.com/viewarticle/524716

Yael Waknine

March 2, 2006 — The US Food and Drug Administration (FDA) has approved

orphan drug status for amphotericin B inhalation powder in the

prevention of pulmonary fungal infections in patients at risk for

aspergillosis due to immunosuppressive therapy; a monoclonal antibody

for the treatment of new-onset type 1 diabetes mellitus; and an orally

active, small-molecule drug for the treatment of Gaucher disease.