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news.The FDA has issued a complete response letter to Strativa Pharmaceuticals (Strativa) regarding the new drug application (NDA) for Zuplenz (ondansetron) oral soluble film. It is intended for the prevention of nausea and vomiting associated with highly-and-moderately-emetogenic chemotherapy, radiotherapy and surgery.
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The new drug application (NDA) for Zuplenz was accepted for review by the FDA in June 2009, and a response is expected in the first quarter of 2010 as mandated by the Prescription Drug User Fee Act (PDUFA) guidelines.
The FDA said that due to an agency-wide restriction on foreign travel in India, it 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.
Furthermore, the FDA has advised that they will schedule and perform an inspection of these sites as soon as possible. Strativa is expected to continue to work with the FDA on completing these site inspections and finalisation of product labeling. No issues related to the study data or film product were identified.