Strativa's New Drug Application For Ondansetron Orally Dissolving Film Strip Accepted By FDA

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 11 Jun 2009 - 5:00 PDT

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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. commercialization rights to ondansetron orally dissolving film strip.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals is the proprietary products division of Par Pharmaceutical, Inc. Strativa is committed to developing and marketing novel prescription drugs. Its initial focus is on supportive care therapeutics in HIV and oncology. Drawing on the specialty products expertise of its staff, Strativa possesses the resources to prepare products for commercialization and to help ensure their success after launch.

About Par Pharmaceutical

Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

Safe Harbor Statement

Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's Annual Report on Form 10-K for the year ended December 31, 2008, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.

Source: Par Pharmaceutical Companies, Inc