Cytomegalovirus
FDA Approves Valcyte(R) (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
Published in Cardiovascular Device Liability Week, September 20th, 2009
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Valcyte (valganciclovir hydrochloride) 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. The FDA also approved a new pediatric oral solution formulation for Valcyte, which will allow easier administration to pediatric patients 4 months to 16 years of age.
"Children receiving organ transplants are especially vulnerable to infection because of their reduced immunity, and the invasive procedure of a transplant can put them at higher risk of...
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