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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  liposomal cyclosporine for inhalation
Date Designated:  06/24/2008
Orphan Designation:  Prevention of bronchiolitis obliterans.
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Zambon S.p.A.
Via Lillo del Duca 10
Bresso, MI 20091

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.