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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: hydrogen sulfate salt is a white or off white crystalline powder with a molecular weight of 352.42 Da [C11H24N6O5S], prepared in a 1:1 ratio of sulfuric acid (MW 98.06 DA) and ENA-001 (free base; MW 254.36 Da [C11H22N6O].
Date Designated: 09/28/2022
Orphan Designation: Treatment of Apnea of Prematurity
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Enalare Therapeutics Inc.
161 Hodge Rd
Princeton, New Jersey 08540
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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