Mylan launches generic Malarone tablets

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prophylaxis of Plasmodium falciparum malaria and the treatment of acute, uncomplicated P. falciparum malaria.

Atovaquone and Proguanil Hydrochloride tablets, 62.5mg/25mg and 250mg/100mg, had US sales of approximately $89.4m for the 12 months ending 31 March 2014, according to IMS Health.

Currently, Mylan has 299 ANDAs pending FDA approval representing $105.2bn in annual brand sales, according to IMS Health. A total of 41 of these pending ANDAs are potential first-to-file opportunities, representing $25.4bn in annual brand sales, for the 12 months ending 31 December 2013, according to IMS Health.