Artesunate suppository authorised for procurement by Global Fund

Special Programme for Research and Training in Tropical Diseases (TDR) news item, 15 December 2016

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A 100mg artesunate suppository originally developed and tested by TDR, now produced as bioequivalent by Cipla, has been placed on the list of malaria pharmaceutical products classified as quality assured by the Expert Review Panel of the Global Fund to Fight AIDS, Tuberculosis and Malaria. This is the first Good Manufacturing Product artesunate suppository authorized for purchase for pre-referral management of severe malaria by the Global Fund, and marks a major milestone in providing quality severe malaria treatment for children. Although the WHO Guidelines for the treatment of malaria recommend use of rectal artesunate, there has been no product with WHO prequalification or marketing authorisation by a stringent regulatory authority available for procurement or use. This has prevented malaria endemic countries from using this life-saving treatment.

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