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Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted by FDA
Date:6/10/2009

WOODCLIFF LAKE, N.J., June 10 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ondansetron orally dissolving film strip (ODFS). Strativa is seeking approval of ondansetron ODFS for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

The ODFS, a new oral formulation of ondansetron designed to rapidly dissolve on the tongue, was developed using MonoSol Rx' proprietary PharmaFilm(TM) thin film technology. In clinical studies, this formulation demonstrated bioequivalence to ondansetron orally disintegrating tablets (ODT), both with and without water. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, Strativa expects the FDA will complete its review or otherwise respond to the NDA by the first quarter of 2010.

"We are very pleased with the acceptance of our NDA submission and look forward to cooperating with the FDA on its review," said John A. MacPhee, President, Strativa Pharmaceuticals. "We believe the quick dissolving film strip formulation of ondansetron offers a convenient and easy-to-administer option for managing nausea and vomiting associated with chemotherapy, radiotherapy and surgery."

Nausea and vomiting is a common side effect associated with chemotherapy, radiation and surgery. Left untreated, nausea and vomiting can have serious consequences such as exhaustion, dehydration and undernourishment, which can interfere with treatment and healing.

In June 2008, Strativa and MonoSol Rx entered into an exclusive licensing agreement under which Strativa acquired the U.S. commercializat
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SOURCE Par Pharmaceutical Companies, Inc.
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