Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip Accepted...

* Reuters is not responsible for the content in this press release.

Wed Jun 10, 2009 8:00am EDT

Strativa's New Drug Application for Ondansetron Orally Dissolving Film Strip
Accepted by FDA

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. 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. For additional information, please
visit www.strativapharma.com.

About Par Pharmaceutical
Par Pharmaceutical, Inc. develops, manufactures and markets generic drugs and
innovative branded pharmaceuticals for specialty markets. For press release
and other company information, visit www.parpharm.com.

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.

Allison Wey, Investor Relations and Corporate Affairs for Par Pharmaceutical
Companies, Inc., +1-201-802-4000
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.