Cerovene Generic Daraprim Approved

FDA has approved a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals’ Daraprim (pyrimethamine) tablets for treating toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide. Severe toxoplasmosis is more likely in pregnant women and individuals who have weak immune systems, such as those with HIV or AIDS, those taking certain types of chemotherapy and those who have recently received an organ transplant, an agency release says. The most common side effects for pyrimethamine include hypersensitivity reactions that can occasionally be severe, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, erythema multiforme, anaphylaxis shock and hyperphenylalaninemia (elevated concentration of the amino acid phenylalanine in the blood), particularly when pyrimethamine is administered at the same time as a sulfonamide.