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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III)
Date Designated: 12/29/2015
Orphan Designation: Treatment of invasive aspergillosis.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Basilea Pharmaceutica International, Ltd., Allschwil
Hegenheimermattweg 167b
Allschwil 4123
Switzerland

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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