Incomplete plant inspections prevent Zuplenz approval

Unable to complete necessary plant inspections in India, Strativa Pharmaceuticals and Par Pharmaceuticals said today that the FDA couldn't approve the NDA for Zuplenz (ondansetron). The drug is an oral soluble film that prevents nausea and vomiting associated with 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," Strativa says in a statement. The FDA plans to inspect the Indian sites as soon as possible. Fortunately for the companies, the agency did not cite any issues related to the study data or film product.

- here's Par's release

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