FDA Announces Antiemetic Drug Discontinuation

The discontinuation of Zofran Oral Solution is not due to manufacturing, product quality, safety or efficacy concerns
The discontinuation of Zofran Oral Solution is not due to manufacturing, product quality, safety or efficacy concerns

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. 

Related Articles

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.

Loading links....