Cerovene Inc has received the US Food and Drug Administration approval for the first generic version of pyrimethamine (Daraprim), a drug used to treatc.
Toxoplasmosis is a parasitic infection caused by Toxoplasma gondii, resulting in flu-like symptoms, which when severe, can cause damage to the brain, eyes or other organs. It is generally transmitted through intake of undercooked contaminated meat or shellfish, exposure from infected cat faeces, or mother-to-child transmission during pregnancy.
Pyrimethamine tablet is used with a sulfonamide for the treatment of toxoplasmosis.
FDA cautions usage of pyrimethamine in patients with known hypersensitivity to pyrimethamine or with documented megaloblastic anaemia due to folate deficiency.
The approval helps individuals susceptible to toxoplasmoses, such as pregnant women and people with HIV or AIDS by paving the way for more choices in treatment options, says FDA.