SUPERGEN ANNOUNCES WITHDRAWAL OF ORATHECIN NDA

SuperGen has withdrawn its new drug application (NDA) for Orathecin capsules based on feedback indicating that the current data package would not be sufficient to gain approval for Orathecin (rubitecan) in the U.S. at this time.

Orathecin is SuperGen's investigational drug for the treatment of pancreatic cancer patients who have failed at least one prior chemotherapy regimen. SuperGen's decision to withdraw the filing was based on discussions with both the FDA and consultants helping the company dialog with the agency regarding the Orathecin NDA.