Navigation Links
MonoSol Rx Announces FDA Acceptance of NDA for Ondansetron Orally Dissolving Film Strip
Date:6/10/2009

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 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.

    Contacts:

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

    The Ruth Group (on behalf of MonoSol Rx)
    Jason Rando (media)
    (646) 536-7025
    jrando@theruthgroup.com

    Sara Pellegrino (investors)
    (646) 536-7002
    spellegrino@theruthgroup.com


'/>"/>
SOURCE MonoSol Rx
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:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... ... March 23, 2017 , ... The IoT (Internet of Things) is revolutionizing ... a huge impact on businesses and individual consumers alike. Laboratories can maximize their ... a value anywhere from $4 trillion to $11 trillion dollars by the year 2025. ...
(Date:3/23/2017)... TX (PRWEB) , ... March 23, 2017 , ... March ... organs that pack a punch when it comes to maintaining good health. Every day, ... 30 minutes, your kidneys filter every drop of your blood, eliminating waste, regulating fluid ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... program owned and organized by HMP Communications Holdings, LLC, today announced that ... within its nationwide network of wound centers interested in becoming Certified Wound Specialist ...
(Date:3/23/2017)... ... March 23, 2017 , ... After raising more than $1.135 million ($1,479,231 AUD) ... travel pillow in crowdfunding history, has established a U.S. Headquarters in New York ... to Americans. , “We’re excited to be operating on U.S. shores, where most of ...
(Date:3/23/2017)... Grants Pass, OR (PRWEB) , ... March 23, 2017 , ... ... Power of Water, Global Climate Change and Your Health on VoiceAmerica, recently talked on ... 22nd, but she also used the occasion to remind listeners of an important distinction. ...
Breaking Medicine News(10 mins):
(Date:3/23/2017)... March 23, 2017 Newborns are highly ... most vaccines because their young immune systems typically ... Children,s Hospital report achieving strong vaccine responses in ... model before human trials — by adding compounds ... In two simultaneous papers, they also describe improved ...
(Date:3/23/2017)... , March 23, 2017 /PRNewswire/ - INVICTUS MD ... IVITF; FRA: 8IS) Invictus MD announces that AB Laboratories ... in its licensed production facility under the Access to ... Hamilton, Ontario . The ... in October 2016, is currently operating at half capacity, ...
(Date:3/23/2017)... NEW YORK , March 23, 2017 /PRNewswire/ ... the NASDAQ Composite ended the trading session at ... edged 0.03% lower, to finish at 20,661.30; and ... 0.19%. Gains were broad based as six out ... This Thursday, Stock-Callers.com has initiated reports coverage on ...
Breaking Medicine Technology: