Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, 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 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, 62.5 mg/25 mg and 250 mg/100 mg, had US sales of approximately $89.4 million for the 12 months ending March 31, 2014, according to IMS Health.
Currently, Mylan has 299 ANDAs pending FDA approval representing $105.2 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending December 31, 2013, according to IMS Health.