Navigation Links
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

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

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.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
3. KineMed to Collaborate With Merck KgaA to Validate New Applications for Drug Development Candidates
4. MichBio Announces Expo Tours; Extends Deadline for Innovator Showcase Applications
5. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
6. Isis Announces $4.2 Million in Government Contracts Awarded to Its Ibis Subsidiary for Biodefense Applications Development
7. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
8. Nitecs IND Application for Clinical Development With Lodotra Accepted by the FDA
9. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
10. National Stem Cell Holding Announces Patent Application for Newly Discovered Cellular Derived Biomaterials for Anti-Aging Applications
11. Laser Energetics to Integrate BrightStar(TM) Alexandrite Lasers in Medical and Dental Applications
Post Your Comments:
(Date:12/1/2015)...  Symic, a clinical-stage biotherapeutics company developing multiple compounds ... announced that it has secured $25 million in a ... its lead candidates SB-030 and SB-061. The financing was ... all existing major investors, as well as several new ... by Symic to over $43 million since being founded ...
(Date:12/1/2015)... Texas (PRWEB) , ... December 01, 2015 , ... Matthew ... his new post, VerMilyea will oversee all IVF lab procedures as well ... and fertility preservation. , “We traveled 7,305 miles to Auckland, New Zealand to bring ...
(Date:11/30/2015)... ... November 30, 2015 , ... Global Stem Cells Group ... in the Santiago Marriott. The Global Stem Cells Group GMP facility is equipped ... of qualified medical researchers and practitioners, experienced in administering stem cell protocols using ...
(Date:11/30/2015)... -- Partnership includes an MPP ... the u niversity , s Solid Drug ... cale - up through ... Africa , where licensees based anywhere in the world will have the right ... Africa , where licensees based anywhere in the world will have ...
Breaking Biology Technology:
(Date:11/2/2015)...  SRI International has been awarded a contract of ... to the National Cancer Institute (NCI) PREVENT Cancer Program ... modern testing and support facilities, and analytical instrumentation to ... studies to evaluate potential cancer prevention drugs. ... Drug Development Program is an NCI-supported pipeline to bring ...
(Date:10/29/2015)... 2015  Connected health pioneer, Joseph C. Kvedar ... technology-enabled health and wellness, and the business opportunities that ... The Internet of Healthy Things . Long before ... existed, Dr. Kvedar, vice president, Connected Health, Partners HealthCare, ... moving care from the hospital or doctor,s office into ...
(Date:10/27/2015)... 27, 2015 Synaptics Inc. (NASDAQ: SYNA ), ... Google has adopted the Synaptics ® ClearPad ® ... power its newest flagship smartphones, the Nexus 5X by ... --> --> Synaptics works ... strategic collaboration in the joint development of next generation ...
Breaking Biology News(10 mins):