Valcyte approved for cytomegalovirus (CMV) disease prevention in pediatrics

The FDA has approved Valcyte (valganciclovir hydrochloride [prodrug of ganciclovir], from Roche) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease. Additionally, the FDA has approved a pediatric oral solution formulation for Valcyte. Valcyte oral solution is expected to be available in January 2010 as a 50mg/1mL dosage strength solution in 100mL bottles in tutti-frutti flavor.  

Valcyte is already indicated in adults for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk.

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