FDA approves first generic of Daraprim

March 3, 2020

The U.S. Food and Drug Administration (FDA) 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 Inc.

“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,” said FDA Commissioner Stephen M. Hahn, M.D.

Toxoplasmosis is an infection caused by a single-celled parasite called Toxoplasma gondii that, when severe, can cause damage to the brain, eyes or other organs. A Toxoplasma infection can occur, among other ways, by eating undercooked, contaminated meat or shellfish; drinking water contaminated with Toxoplasma; or by accidental swallowing of the parasite through contact with cat feces that contain Toxoplasma. It is considered to be the leading cause of death attributed to foodborne illness in the United States.

Severe toxoplasmosis is more likely in pregnant women and individuals who have weak immune systems, such as those with HIV or AIDS, those taking certain types of chemotherapy and those who have recently received an organ transplant. However, occasionally even persons with healthy immune systems may experience eye damage from toxoplasmosis.

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines. Generic prescription drugs approved by the FDA have the same safety and efficacy as brand-name drugs, and the manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs. FDA analysis has shown that greater competition among generic drug makers is associated with lower generic drug prices.

One area of focus under the action plan is improving the efficiency of the generic drug development, review and approval process, as well as closing loopholes that allow brand-name drug companies to delay the generic competition. As part of these important efforts, the FDA maintains a list of off-patent, off-exclusivity drug products without an approved generic to improve transparency and encourage the development and submission of applications for drugs with limited competition. Pyrimethamine is included on this list. The FDA also prioritizes the review of submissions for generic drugs for which there are fewer than three approved generic versions for the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD.

Additionally, certain “gaming” tactics have been used at times to delay generic competition. One example is when brand-name drug manufacturers attempt to prevent potential generic applicants from obtaining samples of certain medicines necessary to support approval of a generic drug application. To improve transparency about this issue, the FDA posted a list identifying all drugs for which the FDA has received an inquiry related to limited distribution of the reference drug from a prospective generic applicant. Daraprim is on this list.

FDA has the announcement