Mylan announced it has received final approval for its Abbreviated New Drug Application (ANDA) for Atovaquone and Proguanil HCl Tablets, the generic version of GlaxoSmithKline’s Malarone.

Malarone is indicated for the prophylaxis of Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and Proguanil HCl interfere with 2 different pathways involved in the biosynthesis of pyrimidines required for nucleic acid replication. Atovaquone is a selective inhibitor of parasite mitochondrial electron transport. Proguanil HCl primarily exerts its effect by means of the metabolite cycloguanil, a dihydrofolate reductase inhibitor. Inhibition of dihydrofolate reductase in the malaria parasite disrupts deoxythymidylate synthesis.

RELATED: Malaria Patient Information Fact Sheet

Atovaquone Proguanil HCl is available in 62.5mg/25mg and 250mg/100mg strength tablets. Mylan has started shipping the product.

For more information call (800) 796-9526 or visit