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

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."

The anti-emetic market totaled 4.1 million prescriptions in 2008. Ondansetron was the prescription leader in the category, accounting for 95% of prescriptions.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films. PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialized over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programs that will generate long-term value.

The Company's commercialization strategy for all PharmFilm(R) products is to partner with the innovator, other specialty pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm(R) formulations represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).

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


    MonoSol Rx:
    Keith Kendall
    Chief Financial Officer
    (732) 564-5000

    The Ruth Group (on behalf of MonoSol Rx)
    Jason Rando (media)
    (646) 536-7025

    Sara Pellegrino (investors)
    (646) 536-7002

Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
2. MonoSol Rx Granted U.S. Article of Manufacture Patent
3. MonoSol Rx Enters Agreement with Hikma Pharmaceuticals PLC for Thin Film Pharmaceutical Products in the Middle East
4. MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA
5. MonoSol Rx to Present at the 20th Annual Piper Jaffray Health Care Conference
6. Strativa Pharmaceuticals Acquires Commercialization Rights to Thin Film Formulation of Ondansetron From MonoSol Rx
7. MonoSol Rx Licenses Thin Film Formulation of Ondansetron to Strativa Pharmaceuticals, a Division of Par Pharmaceutical
8. MonoSol Rx Names Vincent Viviani Senior Vice President, Manufacturing and Operations
9. MonoSol Rx Granted US Patent for Thin Film Manufacturing Process
10. InteKrin Therapeutics Announces INT131 Phase 2a Results at the 2009 American Diabetes Association Annual Meeting
11. Forterus Inc. Announces Special Board Meeting; Nominates Jeff Walton, Former Bear Stearns President, to Board of Directors
Post Your Comments:
(Date:11/30/2015)... ... 2015 , ... Thermi™, a world leader in thermistor-regulated energy ... temperature controlled radiofrequency platform has received CE marking and may now be sold ... as a clinical endpoint. The technology has been available in the United ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... the driverless vehicle experience this summer, ushering in a new era of publicly ... driverless and electric shuttle, will continue to offer guests an up-close look at ...
(Date:11/30/2015)... ... November 30, 2015 , ... On Saturday, October 24th, 2015, at the Mill ... fundraising event, a 5K walk known as “Making Strides Against Breast Cancer”. Patients and ... is also located in Battle Creek, joined in for this campaign that sought to ...
(Date:11/30/2015)... , ... November 30, 2015 , ... ... off its annual fundraising campaign to raise funds for its research, education, support, ... 10% of the organization’s annual funding. , The Mesothelioma Applied Research Foundation, which ...
(Date:11/30/2015)... ... November 30, 2015 , ... According to Los Angeles bariatric surgeon Michael ... not necessarily caused by real hunger, but instead by a hormone called ghrelin ... that, while many patients are aware that weight loss surgery can help patients lose ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... 2015 (HK$,000)For the Six Months Ended 30 September 2015 2014RestatedChange%Turnover 545,575 ... 421,979 , 384,242 , 9.8 ... 34,719 , (18.3) Medical Insurance Administration Service Income ... 16.1 Medical Devices and Accessories Sales , 89,645 ... Medicines Sales , 2,822 , 2,917 ...
(Date:11/30/2015)... WOODCLIFF LAKE, N.J. and SAN ... Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) ... (FDA) has accepted for filing the New Drug Application ... approved, the extended release formulation will offer patients a ... ® ) is currently approved as ...
(Date:11/30/2015)... CHICAGO , Nov. 30, 2015   Nuance ... The National Decision Support Company (NDSC) today ... support and collaboration capabilities that utilize the American College ... and healthcare provider organizations to comply with current ... --> --> By combining clinical ...
Breaking Medicine Technology: