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Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (PRX), and MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, announced the submission of a New Drug Application (NDA) to the U.S. FDA for the orally dissolving film strip (ODFS) formulation of ondansetron.
The NDA is supported by positive data from completed pivotal studies in which ondansetron ODFS demonstrated bioequivalence against GlaxoSmithKline's Zofran ODT(R) anti-emetic product. The ondansetron ODFS product has been developed as an anti-emetic therapy for the prevention of chemotherapy-induced nausea and vomiting (CINV), nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
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