Mylan launches generic version of GlaxoSmithKline's Malarone tablets

PITTSBURGH — Mylan on Thursday announced that it has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets. 

Mylan received final approval from the Food and Drug Administration for its abbreviated new drug application for this product, which is indicated to prevent Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria.

Atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, had U.S. sales of approximately $89.4 million for the 12 months ended March 31, 2014, Mylan reported, citing IMS Health.