Delays in US approval of Hana's Zensana

Hana Biosciences says that its US New Drug Application for Zensana (ondansetron HCI) has been delayed. Hana is seeking approval of the oral spray product for the prevention of nausea and vomiting as a result of chemotherapy, radiation and surgery.

However, on-going long-term stability studies have detected small amounts of precipitated material in scale-up batches of Zensana, which may require an adjustment to the formulation and/or the manufacturing process. Hana is currently investigating this issue, and awaits results of on-going experiments, but noted that this development is likely to delay Food and Drug Administration approval of Zensana beyond the expected Prescription Drug User Fee Act action date of April 30, 2007.

Mark Ahn, Hana chief executive, said :"we are disappointed by this development with Zensana; however, we are committed to improving stability and pursuing FDA approval of what we believe is a high quality product of real value to patients. In the meantime, we are putting expenses related to Zensana commercialization on hold. We will also continue to focus our resources on the development of our high-value oncology product candidates."