Strativa Pharmaceuticals, the proprietary products division of a wholly ownedsubsidiary of Par Pharmaceutical Companies, Inc., has announcedthat the FDA has accepted its New DrugApplication (NDA) for ondansetron orally dissolving film strip (ODFS).Strativa is seeking approval of ondansetron ODFS for the prevention of nauseaand vomiting associated with highly- and moderately-emetogenic chemotherapy,radiotherapy and surgery. The ODFS, a new oral formulation of ondansetron designed to rapidlydissolve on the tongue, was developed using MonoSol Rx’ proprietaryPharmaFilm(TM) thin film technology. In clinical studies, this formulationdemonstrated bioequivalence to ondansetron orally disintegrating tablets(ODT), both with and without water. Pursuant to Prescription Drug User Fee Act(PDUFA) guidelines, Strativa expects the FDA will complete its review orotherwise respond to the NDA by the first quarter of 2010. “We are very pleased with the acceptance of our NDA submission and lookforward to cooperating with the FDA on its review,” said John A. MacPhee,President, Strativa Pharmaceuticals. “We believe the quick dissolving filmstrip formulation of ondansetron offers a convenient and easy-to-administeroption for managing nausea and vomiting associated with chemotherapy,radiotherapy and surgery.” Nausea and vomiting is a common side effect associated with chemotherapy,radiation and surgery. Left untreated, nausea and vomiting can have seriousconsequences such as exhaustion, dehydration and undernourishment, which caninterfere with treatment and healing. In June 2008, Strativa and MonoSol Rx entered into an exclusive licensingagreement under which Strativa acquired the U.S. commercialization rights toondansetron orally dissolving film strip.
