Pediatrics

FDA approves ZOFRAN for use in children as young as 1 month of age

Published in Medical Letter on the CDC and FDA, May 1st, 2005

GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for ZOFRAN (ondansetron hydrochloride) Injection to prevent nausea and vomiting associated with general anesthesia in children as young as 1 month of age and nausea and vomiting associated with chemotherapy in children as young as 6 months of age.

The sNDA was filed on September 28, 2004 and was granted priority review status by the FDA. This new indication makes ZOFRAN the only medication approved to prevent postoperative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV) in infants, the company says. ZOFRAN was...

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Source: Medical Letter on the CDC and FDA (2005-05-01)

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