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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (1,3)-ß-D-glucan synthesis inhibitor
Date Designated: 08/22/2016
Orphan Designation: Treatment of invasive Aspergillus infections
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
One Evertrust Plaza, 13th Floor
Jersey City, New Jersey 07302
United States

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.