Mylan Inc. (MYL) said 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 U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for this product, indicated for the prophylaxis of Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria.
According to IMS Health, Atovaquone and Proguanil Hydrochloride Tablets, 62.5 mg/25 mg and 250 mg/100 mg, generated U.S. sales of around $89.4 million for the year to March 31, 2014.
Currently, Mylan has 299 ANDAs pending FDA approval representing $105.2 billion in annual brand sales; while 41 of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for 2013, according to IMS Health.
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