Hana Biosciences submits NDA for Zensana oral spray for chemotherapy-induced vomiting

By Lisa Kerner

Charlotte, N.C., June 30 - Hana Biosciences said it has submitted a New Drug Application to the Food and Drug Administration seeking marketing approval for Zensana (ondansetron HCl) oral spray for the prevention of nausea and vomiting associated with chemotherapy, radiotherapy and post-operative induced nausea and vomiting.

Upon approval, the company plans a U.S. launch of the product in the first half of 2007.

Zensana is a 5-HT3 antagonist that delivers standard antiemetic therapy (ondansetron), in a convenient, micromist oral spray.

Based on clinical trial data, Hana said it believes Zensana is statistically bioequivalent to ondansetron tablets with faster initial delivery.

Hana licensed from NovaDel Pharma, Inc. the exclusive rights to market the oral spray formulation in the United States and Canada.

Based in South San Francisco, Calif., Hana acquires, develops and commercializes products for the treatment of cancer.

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