FDA finally approves Strativa's Zuplenz

5 July 2010

Strativa Pharmaceuticals, a unit of Par Pharmaceuticals, announced on Friday that the US Food and Drug Administration had approved Zuplenz (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medicine, the firm noted.

The FDA delayed approval of the drug back in February because of travel restrictions, which prevented it completing necessary plant inspections in India, but at the time the agency did not cite any issues related to the study data or film product.

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