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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: fixed dose combination of pyronaridine tetraphosphate and artesunate
Date Designated: 09/27/2018
Orphan Designation: Treatment of malaria
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shin Poong Pharmaceutical Co., Ltd.
161 Yoksam-Ro, Gangnam-Gu
Seoul, Seoul
South Korea

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.