Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies Inc. (PRX), said the FDA has indicated that it cannot approve the application for Zuplenz at this time, as it has not completed its inspection of the bioequivalence study sites due to an agency-wide restriction on foreign travel to India.
The company's Zuplenz oral soluble film is indicated for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.
In its letter, the FDA advised that they will schedule and perform an inspection of these sites as soon as possible.
Strativa said it 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, the company added.
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