FDA approves first generic of Daraprim

The US Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).

The sponsor of the approved generic version of Daraprim tablets is Cerovene. The branded version is from Vyera, a company once headed by Martin Shkreli (who is serving a seven-year prison sentence) that was formerly Turing Pharmaceuticals, which bought the rights from Impax in 2015.

“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 Dr Stephen Hahn.