The FDA has approved Zuplenz (ondansetron oral soluble film, from Strativa) for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. This approval was based on clinical study data comparing the bioequivalence of Zuplenz 8mg to Zofran ODT 8mg that demonstrated that a single dose of Zuplenz was comparable to Zofran ODT. Zuplenz uses MonoSol Rx’s proprietary PharmFilm oral soluble film technology to rapidly dissolve on the tongue without the need for water.
Zuplenz will be offered in 4mg and 8mg dosage strengths, and is expected to be available in the third quarter of 2010.
For more information call (201) 802-4000 or visit www.strativapharma.com.