On Friday, the U.S. Food and Drug Administration (FDA) announced the approval of the first generic version of brand Daraprim (pyrimethamine), which is prescribed for the treatment of toxoplasmosis, a parasitic infection caused by Toxoplasma gondii.
FDA Commissioner Dr. Stephen Hahn said, “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,” he 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,” added Dr. Hahn.
“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,” he said.
Severe toxoplasmosis infection could damage the brain, eyes or other organs. This parasitic infection occurs when you eat undercooked or contaminated meat or shellfish. You may even catch the infection by drinking water contaminated with Toxoplasma.
In the United States, toxoplasmosis is one of the leading causes of death associated with foodborne illnesses.
Pyrimethamine acts by inhibiting the enzyme dihydrofolate reductase, which interferes with the regeneration of tetrahydrofolic acid from dihydrofolate. Tetrahydrofolic acid is important for DNA and RNA synthesis in many microorganisms, including protozoa such as Toxoplasma gondii.
Some of the most common side effects of pyrimethamine are anorexia and vomiting. The drug is not advised to patients with a known history of pyrimethamine allergy or megaloblastic anemia due to folate deficiency. Women who take pyrimethamine should not become pregnant. The sponsor of the FDA approved generic Daraprim tablets is Cerovene Inc.
