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. 2011 Feb 1;8(2):e1000411. doi: 10.1371/journal.pmed.1000411

Table 1. Sample of novel neglected disease products presented to regulators since 2005 [8],[11],[12],[20][23].

Novel Neglected Disease Products Regulatory Stage
Artesunate-amodiaquine ASAQ (malaria) Approved by 24 African countries
WHO prequalified (October 2008)
Artesunate-mefloquine ASMQ (malaria) Approved by Brazilian ANVISA (April 2008)
Coartem Dispersible (malaria) Approved by 14 African countries
Approved by Swissmedic (December 2008)
WHO prequalified (February 2009)
Intramuscular paromomycin (visceral leishmaniasis) Received FDA and EMA orphan drug designation (March 2005)
Approved by Drugs Controller General of India (August 2006)
Eurartesim (malaria) Submitted to EMA for approval (July 2009)
Moxifloxacin (TB) Clinical development plan submitted to developing country and/or Western regulators
PA-824 (TB) Clinical development plan submitted to developing country and/or Western regulators
Arterolane/PQP (malaria) Clinical development plan submitted to developing country and/or Western regulators
Azithromycin-chloroquine AZCQ (malaria) Clinical development plan submitted to developing country and/or Western regulators
Fexinidazole (sleeping sickness) Clinical development plan submitted to developing country and/or Western regulators

Additional source: correspondence with Novartis.