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Artesunate FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 27, 2020.

FDA Approved: Yes (First approved May 26, 2020)
Generic name: artesunate
Dosage form: for Injection
Company: Amivas (US), LLC
Treatment for: Malaria

Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

Development timeline for artesunate

May 27, 2020Approval FDA Approves Artesunate for Injection for the Treatment of Severe Malaria
Jul 23, 2019La Jolla Pharmaceutical Company Receives Orphan Designation from FDA for LJPC-0118 (Artesunate) for the Treatment of Malaria

Further information

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