The decision came after the company’s investigation of a previously reported precipitation issue. As a result, Hana has chosen to withdraw a new drug application previously submitted to the FDA, without prejudice.
In June 2006, Hana submitted a new drug application for Zensana with the FDA to seek approval for the prevention of nausea and vomiting as a result of chemotherapy, radiation, and surgery.
Hana’s partner and licensor, NovaDel Pharma, has developed an alternate formulation of the product. This new formulation is currently under active investigation and scale-up, and Hana plans to work with NovaDel to evaluate the new formulation.