FDA Announces Antiemetic Drug Discontinuation
Zofran Oral Solution, a selective 5-HT3 receptor antagonist, is indicated for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin ≥50mg/m2; prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy; prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen; and prevention of post-op nausea and vomiting.
The discontinuation of Zofran Oral Solution is not due to manufacturing, product quality, safety or efficacy concerns. The affected product was supplied as a 4mg/5mL strength in 50mL bottles (NDC 0173-0498-00) in a strawberry flavor.
Zofran is still available as tablets, orally disintegrating tablets, and as an injection for intravenous (IV) or intramuscular (IM) routes.
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