Agouron's Viracept To Be Given To Children

Agouron Pharmaceuticals is to make its HIV protease inhibitor, Viracept(nelfinavir mesylate), available without charge to HIV-infected children between the ages of two and 13 in a US Food and Drug Administration expanded-access program.

This is the first protease inhibitor to become available for pediatric use as no pediatric formulation of a PI has yet been approved by the FDA; PIs have been given to only a small number of children enrolled in clinical trials. Although the FDA has ruled that PIs approved for adults may be administered to children, pediatricians have been reluctant to go ahead without sufficient clinical data on issues such as dosing, reports the Wall Street Journal.

NDA Submitted For Adult And Pediatric Formulations Agouron submitted a New Drug Application to the agency last month for both an adult tablet formulation and a pediatric oral powder which can be mixed with milk, formula or soft foods.