GlaxoSmithKline says that the US Food and Drug Administration has approved two new indications for its anti-nausea drug, Zofran (ondansetron).
Specifically, Zofran injection has won the green light to prevent nausea and vomiting associated with general anesthesia in children as young as one month of age, and nausea and vomiting associated with chemotherapy in children as young as six months of age.
The UK firm filed supplemental New Drug Application with the FDA late in September last year and says that the backing makes it the only medication approved to prevent post-operative nausea and vomiting and chemotherapy-induced nausea and vomiting in infants. Zofran was previously the first product to receive a pediatric indication for the prevention of PONV and CINV in children two years of age and older.
