Hana Biosci submits NDA on Zensana

South San Francisco, USA-based cancer specialist Hana Biosciences says that the Food and Drug Administration has accepted for review its New Drug Application for Zensana (ondansetron HCI) oral spray, which the firm submitted seeking approval for the prevention of chemotherapy, radiation and post-operative associated nausea and vomiting.

The acceptance of the filing means the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review. Hana completed bioequivalence and bioavailability clinical trials of Zensana near the start of the year and submitted its NDA on June 30, and so expects the agency's decision in April 2007.