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Strativa receives complete response letter for oral film nausea drug; FDA cites travel restrictions to India for inspection
Monday, February 08 2010 | Comments
What's This?
The Food and Drug Administration declined to approve the New Drug Application for Strativa Pharmaceuticals' Zuplenz (ondansetron hydrochloride) oral soluble film for the prevention of chemotherapy- and radiotherapy-related nausea and vomiting and postoperative nausea, citing travel restrictions in India as the reason.Agency officials said they have been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study of Zuplenz "due to an agencywide restriction on foreign travel in India."
Strativa, which is a unit of Par Pharmaceutical Cos. Inc., said the FDA advised that it would schedule and perform site inspections as soon as possible.
The company noted that the FDA has not identified any issues related to the study data or film product.
An oral spray formulation of ondansetron is also in Phase III development in this indication.
Strativa gained the U.S. commercialization rights to the thin film formulation of ondansetron from MonoSol Rx in 2008. Zuplenz was developed with MonoSol Rx's PharmFilm delivery technology.
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