Zuplenz FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 1, 2023.
FDA Approved: Yes (Discontinued) (First approved July 2, 2010)
Brand name: Zuplenz
Generic name: ondansetron
Dosage form: Oral Soluble Film
Company: Aquestive Therapeutics
Treatment for: Nausea/Vomiting, Chemotherapy Induced, Nausea/Vomiting, Postoperative, Nausea/Vomiting, Radiation Induced
Zuplenz (ondansetron) is an oral soluble film formulation of the approved 5-HT3 receptor antagonist ondansetron for the prevention of nausea and vomiting associated with chemotherapy, nausea and vomiting associated with radiotherapy, and postoperative nausea and/or vomiting.
- Zuplenz is indicated for the prevention of:
- nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 , in adults.
- nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy in adults and pediatric patients 4 years of age and older.
- nausea and vomiting associated with radiotherapy in adult patients receiving either total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen.
- postoperative nausea and/or vomiting in adults.
Development timeline for Zuplenz
| Date | Article |
|---|---|
| Jul 5, 2010 | Approval FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film |
Further information
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