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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: allopregnanolone
Date Designated: 04/20/2014
Orphan Designation: Treatment of status epilepticus
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sage Therapeutics
215 First Street
Suite 220
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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