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MonoSol Rx Secures 505(b)(2) Regulatory Pathway for Montelukast Sodium Oral Soluble Film
Date:3/30/2011

armFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals - Zuplenz® (ondansetron) oral soluble film 4 mg and 8 mg, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone®  (buprenorphine and naloxone) sublingual film 2 mg/0.5 mg and 8 mg/2 mg CIII, the first sublingual film product for the treatment of opioid dependence.  

MonoSol Rx's commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing.  PharmFilm® 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). For existing and future partners, PharmFilm® formulations can also represent revenue-life cycle extensions for products with patent lives that have expired or are approaching expiration.  For press releases and other company information visit www.monosolrx.com.

Contacts:

MonoSol Rx:
Keith Kendall
Executive Vice President
(732) 564-5000

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

Joshua Drumm (investors)
(646) 536-7006

SOURCE MonoSol Rx
Copyright©2010 PR Newswire.
All rights reserved

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3. MonoSol Rx Issued Strategic U.S. Patent Governing the Manufacturing of Pharmaceutical Films
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