MonoSol Rx announced the completion of all pivotal bioequivalence studies for a thin film formulation of ondansetron.
Subject to final review of the data and discussions with the FDA, it is anticipated that MonoSol Rx and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (PRX), could file a New Drug Application, or NDA, in early to mid 2009.
According to the company, the ondansetron thin film product is being developed for the prevention of chemotherapy-induced nausea and vomiting, prevention of nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
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