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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: 20-alphaHydroxycholesterol
Date Designated: 08/31/2020
Orphan Designation: Prevention of White Matter Injury in Preterm Infants less than or equal to 32 Weeks Gestational Age
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Tellus Therapeutics, Inc.
517 Summit Trail Drive
Hillsborough, North Carolina 27278
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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