Strativa Pharmaceuticals' Zuplenz NDA: FDA issues complete response letter

Feb 6 2010

Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

Due to an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time.  The FDA advised that they will schedule and perform an inspection of these sites as soon as possible.  Strativa will continue to work with the FDA on completing these site inspections and finalization of product labeling. No issues related to the study data or film product were identified.