FDA Announces Antiemetic Drug Discontinuation

The Food and Drug Administration (FDA) has posted a discontinuation notice for Zofran Oral Solution (ondansetron; Novartis).

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.

For more information call (888) 669-6682 or visit Novartis.com.