The U.S. Food and Drug Administration (FDA) has approved MonoSol Rx’s new drug application (NDA) for ondansetron orally dissolving film strips (ODFS) utilizing the PharmaFilm® technology.
PharmaFilm delivers medication in the form of a thin film strip that rapidly dissolves on the patient’s tongue. This delivery system bypasses the need for water necessary for pills or tablet forms of medication, and reduces volume compared to liquid forms of medication which can exacerbate nausea among patients already suffering from nausea and vomiting.
The NDA is indicated for ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiation therapy and surgery.
The FDA will respond to the NDA by the first quarter of 2010.
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