MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving ... ( WARREN N.J. June 10 /- MonoSol Rx the...)

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MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving Film Strip

Date:6/10/2009

WARREN, N.J., June 10 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, announced today that the new drug application (NDA) for ondansetron orally dissolving film strip (ODFS) has been accepted for review by the U.S. Food and Drug Administration (FDA). Ondansetron ODFS was developed using MonoSol Rx's proprietary PharmFilm(R) technology to deliver the anti-emetic therapy ondansetron in a thin film strip that rapidly dissolves on the tongue.

MonoSol Rx and its partner Strativa Pharmaceuticals, the proprietary products division of Par Pharmaceutical Companies, Inc. (NYSE: PRX), are seeking FDA approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery. The NDA is supported by positive data from successfully completed pivotal bioequivalence studies against ondansetron ODT (orally disintegrating tablets), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to respond to the NDA by the first quarter of 2010.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, "The FDA's acceptance of the NDA for our ondansetron orally dissolving film strip further validates the acceptance of thin film as a new prescription dosage form. With our licensing partner Strativa we are one step closer to providing a promising new formulation of an anti-emetic therapy that leverages our PharmFilm(R) drug delivery technology. By delivering the drug orally through a rapidly dissolving film strip that requires no water, ondansetron ODFS has advantages over tablets or liquid medications, which can exacerbate nausea in these patients."

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