Nausea/Vomiting -- Radiation Induced Blog

FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film

Posted 7 Jul 2010 by Drugs.com

WOODCLIFF LAKE, N.J., July 2 /PRNewswire/ – Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication. The FDA approval was granted based on clinical study data comparing the bioequivalence of Zuplenz 8 mg to Zofran ODT (orally dissolving tablet) 8 mg. The pharmacokinetic results of these studies demonstrated that a single dose of Zuplenz, taken with or without water and under fed and fasting conditions, was comparable to Zofran ODT. "The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment ... Read more

Related support groups: Ondansetron, Nausea/Vomiting -- Chemotherapy Induced, Nausea/Vomiting -- Postoperative, Nausea/Vomiting -- Radiation Induced