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MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
Date:4/9/2009

WARREN, N.J., April 9 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced the submission on April 7, 2009 of a New Drug Application (NDA) to the U.S. Food and Drug Administration (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.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "The submission of the NDA for our ondansetron orally dissolving film strip marks another key milestone for MonoSol Rx and our licensing partner, Strativa Pharmaceuticals. This sets the stage for a promising new therapy to combat nausea resulting from chemotherapy, radiotherapy and surgical procedures. For patients in need of anti-emetic drugs, such as ondansetron, the burden of ingesting a tablet or swallowing a liquid medication can be significant because it has a tendency to exacerbate the nausea. Our PharmFilm(R) technology offers the potential to improve the convenience and compliance of ondansetron by delivering the drug through a quick orally dissolving film strip that requires no water."

In June 2008, MonoSol Rx and Strativa entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercialization ri
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SOURCE MonoSol Rx
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3. MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA
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5. Strativa Pharmaceuticals Acquires Commercialization Rights to Thin Film Formulation of Ondansetron From MonoSol Rx
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