First Generic of Daraprim Gets FDA Approval

The Food and Drug Administration (FDA) has approved the first generic of Daraprim (pyrimethamine) tablets. 

Pyrimethamine, a folic acid antagonist, is indicated for the treatment of toxoplasmosis when used with a sulfonamide. The approved generic version of Daraprim has been granted to Cerovene Inc and will be supplied as 25mg tablets.

Toxoplasmosis is a disease caused by the Toxoplasma gondii parasite. Infection can occur by eating undercooked, contaminated meat or drinking contaminated water. In addition, the parasite may be ingested through contact with infected cat feces. Pregnant women and patients with weakened immune systems (eg, HIV or AIDS) are most susceptible to severe complications from the infection.

“The FDA has a longstanding commitment to increasing competition in markets with limited or no generic alternatives,” said FDA Commissioner Stephen M. Hahn, MD, “[…] 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.”

Daraprim was at the center of much controversy in 2015 when Turing Pharmaceuticals (now Vyera Pharmaceuticals), under the direction of Martin Shkreli, acquired the life-saving drug and subsequently raised the price from $17.50 per tablet to $750 per tablet. In January 2020, the Federal Trade Commission charged Shkreli and Vyera Pharmaceuticals with an anticompetitive scheme that would allow the Company to preserve a monopoly on the drug.

For more information visit fda.gov.