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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: glucagon
Date Designated: 12/05/2012
Orphan Designation: Prevention of hypoglycemia in the congenital hyperinsulinism population
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biodel, Inc.
100 Saw Mill Road
Danbury, Connecticut 06810
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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