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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: (3-amino-5-ethyladamantan-1-yl) methyl nitrate hydrochloride
Date Designated: 10/24/2026
Orphan Designation: treatment of pulmonary arterial hypertension (PAH)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Guangzhou Magpie Pharmaceuticals Co., Ltd.
No.80 Lanyue Road
Room 301, Zone F, Science and Technology Innovation Base, Science City, Huangpu District
Guangzhou, Guangdong 510663
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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