Cerovene has bagged approval from the US Food and Drug Administration (FDA) for its generic version of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis when used with a sulfonamide, a group of medicines for bacterial infections.
Toxoplasmosis is a foodborne infection caused by the parasite Toxoplasma gondii. A severe form of the condition can lead to damage to the brain, eyes or other organs.
The infection can occur following consumption of poorly cooked, contaminated meat or shellfish, drinking water contaminated with Toxoplasma, or when the parasite is swallowed accidentally via contact with cat feces that contain it along with other means.
Severe toxoplasmosis is more probable to occur in pregnant women and individuals having weak immune systems like those having HIV or AIDS. The infection can also occur in people under certain types of chemotherapy and those who have received an organ transplant recently.
However, some times even persons having healthy immune systems can face eye damage from toxoplasmosis.
Stephen M. Hahn – FDA Commissioner 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.
“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.”