Since the discontinuation of quinine marketing in the United States (US), there has been a dire need for a Food and Drug Administration (FDA)-approved treatment for severe malaria. To address this issue, the USFDA has recently approved intravenous artesunate for the treatment of malaria in adult and pediatric patients aged above two years. The discontinuation of the marketing of quinine in the United States in March 2019 left the doctors without a Food and Drug Administration (FDA)-approved treatment for severe malaria.
Under an investigational new drug (IND) protocol, the intravenous (IV) artesunate was only available to treat US patients with severe malaria and those with uncomplicated malaria but unable to take oral medicines. The drug was made available through the FDA’s expanded Access Program. To overcome the lack of approved treatment against severe malaria, the FDA has recently…
