Navigation Links
Strativa Pharmaceuticals Provides An Update On Zuplenz(R) (Ondansetron) Oral Soluble Film
Date:2/5/2010

WOODCLIFF LAKE, N.J., Feb. 5 /PRNewswire-FirstCall/ -- Strativa Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for Zuplenz® (ondansetron) oral soluble film for the prevention of nausea and vomiting associated with highly- and moderately-emetogenic chemotherapy, radiotherapy and surgery.

Due to an agency-wide restriction on foreign travel in India, the FDA has been unable to perform an inspection of the clinical and analytical sites for a bioequivalence study, and therefore, cannot approve the application at this time.  The FDA advised that they will schedule and perform an inspection of these sites as soon as possible.  Strativa will continue to work with the FDA on completing these site inspections and finalization of product labeling. No issues related to the study data or film product were identified.

About Strativa Pharmaceuticals

Strativa Pharmaceuticals, the proprietary products division of a wholly owned subsidiary of Par Pharmaceutical Companies, Inc. (NYSE: PRX), excels at finding, enhancing, and bringing to market drugs that make a meaningful difference to patients. For more information about Strativa, visit www.strativapharma.com.

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets higher barrier to entry generic drugs and niche, innovative proprietary pharmaceuticals. For press release and other company information, visit www.parpharm.com.

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in quick dissolving films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of currently marketed drugs. The Company is a leader in thin film drug delivery and has a strong intellectual property position, a portfolio of commercialized OTC drug products, and a pipeline of prescription formulations utilizing its PharmFilm® technology. With a vertically integrated development and production infrastructure, MonoSol Rx has the capacity to manufacture OTC drug products for near-term revenues that enable the funding of prescription product development programs that will generate long-term value.

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

RELATED LINKS
http://www.parpharm.com
http://www.strativapharma.com

'/>"/>

SOURCE Par Pharmaceutical Companies
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Strativa Pharmaceuticals Development Partner, BioAlliance Pharma, Presents Phase III Study Results of Miconazole Lauriad(R) for the Treatment of Oropharyngeal Candidiasis
2. Strativa Pharmaceuticals Provides Product Pipeline Update
3. Strativa Pharmaceuticals Announces Preliminary Results from ONCONASE(R) Phase IIIb Clinical Trial
4. Strativa Pharmaceuticals Announces Phase III Results for Loramyc(R) to Treat Oropharyngeal Candidiasis
5. Poniard Pharmaceuticals to Present at 12th Annual BIO CEO and Investor Conference
6. Infosys Technologies and Elan Pharmaceuticals Apply Co-creation Model to Transform Discovery Research
7. Lexicon Pharmaceuticals to Present at the 12th Annual BIO CEO & Investor Conference
8. Poniard Pharmaceuticals Announces Management Changes and Reduction in Force
9. Anadys Pharmaceuticals to Present at the BIO CEO & Investor Conference
10. ADVENTRX Pharmaceuticals to Present at the 12th Annual BIO CEO & Investor Conference on February 9
11. ISTA Pharmaceuticals Announces Preliminary, Unaudited Revenue of $110.6 Million in 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... For hospitals considering enrollment in the Federal ... the program, the Health Resources and Services Administration,s (HRSA) ... Mega-Guidance , could have significant impact on plans and ... 2016. Essential Insights , Daniel Neal, ... the Mega-Guidance,s key proposed changes, including a new requirement ...
(Date:2/4/2016)... 2016  SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN ... into a settlement agreement with the United States ... SEC,s investigation into possible violations of the Foreign ... the settlement agreement, SciClone has agreed to pay ... interest and a penalty.  This payment is in ...
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... Identifying and Commercializing First-in-Class Innovation ... disorder associated with chronic inflammation of the airways ... of COPD symptoms make the disease one of ... cause of death in the world. COPD is ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... , ... In sleep, when the defenses of the day are at rest, ... with eating disorders is significant self-criticism, and consequently these patients experience this disease with ... maladaptive means for coping with this unease, but also leads to a reservoir of ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... practical mobile kitchens, recently announced the debut of their latest mobile kitchen model, ... Kitchens provides organizations with modern, high-volume commercial kitchens for use anywhere in the ...
(Date:2/5/2016)... Moscow, Russia (PRWEB) , ... February 05, 2016 , ... ... update has a completely new user interface design and the developer has fixed known ... with those they want to on their phone while not consuming any of their ...
(Date:2/5/2016)... ... , ... –This week, Atascadero water heater company First Call Plumbing ... view the report, click here or see below. , There are ... and cons, the type chosen is almost entirely up to personal preference. However, tankless ...
(Date:2/5/2016)... ... ... tired of trying to cram belongings into spare space that just isn’t there, a self-storage ... before hastily spending money on a unit, take these tips into consideration. , Self-storage is ... often not told when utilizing these services are some tips on how to use the ...
Breaking Medicine News(10 mins):