New FDA Indication for Zofran Tablets

RESEARCH TRIANGLE PARK, NC—Zofran (ondansetron HCl), Glaxo Wellcome’s 5HT3 antagonist antiemetic, has received FDA approval for a new indication and a new tablet strength

Zofran is now indicated for the prevention of nausea and vomiting associated with single-day highly emetogenic cancer chemotherapy in adults, ie, chemotherapy in which the likelihood of nausea and vomiting is greater than 90% without prior antiemetic treatment.

The Zofran dose for highly emetogenic chemotherapy is 24 mg once daily, which can be given via the newly approved 24-mg tablet or three 8-mg tablets.

Zofran is also indicated for the prevention of nausea and vomiting associated with moderately emetogenic chemotherapy in adults and children, the prevention of nausea and vomiting associated with radiotherapy in adults, and the prevention of postoperative nausea and vomiting in adults.