The US FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Quinine Sulfate Capsules USP, 324mg, the generic equivalent to Mutual Pharmaceutical's Qualaquin.
Mylan has commenced shipping the generic medication that is indicated only to treat uncomplicated Plasmodium falciparum malaria.
The antimalarial medication works by inhibiting nucleic acid synthesis, protein synthesis and glycolysis in Plasmodium falciparum bacteria and has the potential to bind with hemazoin in parasitized erythrocytes.
According to IMS Health data, the US sales of Qualaquin supplied for oral administration as capsules containing 324mg of the active ingredient quinine sulfate USP was approximately $31.9m for the year ending 30 September 2012.
