Hana: FDA to review NDA for Zensana oral spray in the prevention of cancer-treatment-induced vomiting

By Lisa Kerner

Charlotte, N.C., Aug. 30 - Hana Biosciences said the Food and Drug Administration will review its New Drug Application for Zensana (ondansetron HCI) Oral Spray.

Specifically, Hana is seeking Zensana approval for the prevention of chemotherapy, radiation and post-operative associated nausea and vomiting.

"Subject to FDA approval, we look forward to a potential commercial launch in the United States in the first half of 2007," president and chief operating officer Mark Ahn said in company news release.

Bioequivalence and bioavailability clinical trials of Zensana, the first 5-HT3 antagonist to deliver ondansetron antiemetic therapy in a spray, were completed earlier this year.

The company said it believes Zensana is statistically bioequivalent to ondansetron tablets.

Hana is a biopharmaceutical company located in South San Francisco, Calif.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.