FDA approves first application for generic Daraprim tablets
The FDA has approved an application for generic Daraprim tablets for the treatment of toxoplasmosis when used with sulfonamide, according to a press release.
Toxoplasmosis is caused by the Toxoplasma gondii parasite, which can cause severe infections in immune compromised patients.
“The FDA has a longstanding commitment to increasing competition in markets with limited or no generic alternatives,” FDA Commissioner Stephen M. Hahn, MD, said in the release. “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. Empowering patients and promoting choice and competition are top priorities for the FDA.”
The high price of Daraprim (pyrimethamine, Vyera Pharmaceuticals) has been widely criticized.
“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,” Hahn said. – by Eamon Dreisbach