FDA issues complete response letter for Zuplenz

WOODCLIFF LAKE, N.J. The Food and Drug Administration has declined to approve a drug made by Strativa Pharmaceuticals for preventing sickness resulting from some cancer treatments, Strativa said Friday.

The FDA issued a complete response letter for Strativa’s approval application for Zuplenz (ondansetron), an oral-soluble film for preventing nausea and vomiting associated with certain types of chemotherapy, radiotherapy and surgery. The FDA cited an agency-wide restriction on travel in India that prevented it from inspecting the clinical and analytical sites for a bioequivalence study.

Strativa said it would work with the FDA to complete inspections of the sites, while the FDA said it would try to perform an inspection as soon as it could.