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:4/20/2017)... , April 20, 2017  Zimmer Biomet Holdings, Inc. ... healthcare, today announced that it will be participating in ... at the InterContinental Hotel in Boston, Massachusetts ... will present at 11:20 a.m. Eastern Time. ... via Zimmer Biomet,s Investor Relations website at http://investor.zimmerbiomet.com ...
(Date:4/20/2017)... 20, 2017   ZappRx, Inc ., a digital health ... process, today announced it closed $25 million in Series B ... firm based in Seattle that is ... . The Series B round included participation from SR ... and GV (formerly Google Ventures). As part of ...
(Date:4/20/2017)... -- Research and Markets has announced the addition ... Analysis By Service (Manufacturing, Research), By Country, (Brazil, Mexico, Colombia, ... report to their offering. ... The Latin American pharmaceutical contract manufacturing services market is ... Low drug registration cost in Latin American countries and continuous ...
Breaking Medicine Technology:
(Date:4/28/2017)... , ... April 28, 2017 , ... Rob Lowe is ... now he has leant his presence to an educational purpose as the host of ... important one being cancer. In a recent episode, the series focuses on thyroid cancer. ...
(Date:4/28/2017)... ... ... Christie Medical Holdings, Inc. , with its market-leading vein finder ... a leader in infusion therapy and pain management. , Intravenous (IV) therapy plays ... patients receiving a peripheral IV catheter as part of their treatment plan. Many hospitals ...
(Date:4/27/2017)... (PRWEB) , ... April 27, 2017 , ... ... Economics Insights in Incentives, Rewards, and Recognition: A Nudge Guide," a groundbreaking analysis ... (IRR) field. Offering practical takeaways to apply immediately to IRR programs, the report ...
(Date:4/27/2017)... ... April 27, 2017 , ... ... On the heels of Thinksport’s award-winning sunscreen they’ve used the same scientific approach ... works! , Countless deodorants flood the aisles that contain harmful chemicals that should ...
(Date:4/27/2017)... ... April 27, 2017 , ... Last night, ... CAREGiverSM of the Year for her extraordinary compassion and lifelong dedication to serve ... American professional caregivers for the prestigious award each year – identifying a CAREGiver ...
Breaking Medicine News(10 mins):