FDA approves Cerovene’s generic Daraprim

Patients with an infection caused by the parasite toxoplasma gondii have a generic treatment available. The Food and Drug Administration gave Cerovene the green light for the first generic of Daraprim (pyrimethamine) tablets when used with a group of medicines used to treat bacterial infections.

"The FDA has a longstanding commitment to increasing competition in markets with limited or no generic alternatives. Through the FDA's Drug Competition Action Plan, we've worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review and approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to 'game' the rules in ways that delay generic competition that Congress intended," said FDA commissioner Stephen Hahn.

Hahn continued, "Empowering patients and promoting choice and competition are top priorities for the FDA. These important efforts include improving access to safe, effective and high-quality generic medications. Today's approval is especially important for populations that are more susceptible to toxoplasmosis infections, such as pregnant women and individuals with HIV or AIDS by paving the way for more choices in treatment options."

Toxoplasmosis is an infection caused by a single-celled parasite called Toxoplasma gondii that, when severe, can cause damage to the brain, eyes or other organs. A Toxoplasma infection can occur, among other ways, by eating undercooked, contaminated meat or shellfish; drinking water contaminated with Toxoplasma; or by accidental swallowing of the parasite through contact with cat feces that contain Toxoplasma. It is considered to be the leading cause of death attributed to foodborne illness in the United States.