www.fdanews.com/articles/196185-first-generic-of-daraprim-approved
First Generic of Daraprim Approved
March 10, 2020
Cerovene gained FDA approval for its generic of Vyera’s Daraprim (pyrimethamine) for treatment of toxoplasmosis when used with a sulfonamide.
FDA Commissioner Stephen Hahn said the approval is especially important for patients such as pregnant women and HIV/AIDS patients who are more susceptible to toxoplasmosis infections.
The New York Attorney General previously filed suit against Vyera Pharmaceuticals for an alleged scheme to monopolize the treatment.